Cleared Traditional

AMERICAN NASAL SPONGE

K872905 · American Silk Sutures, Inc. · Ear, Nose, Throat
Sep 1987
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K872905 is an FDA 510(k) clearance for the AMERICAN NASAL SPONGE, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on September 4, 1987, 42 days after receiving the submission on July 24, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K872905 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1987
Decision Date September 04, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EPP — Splint, Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5800

Similar Devices — EPP Splint, Nasal

All 14
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
K942158 · Wfr/Aquaplast Corp. · Jul 1994
EXTERNAL NASAL SPLINT
K942724 · Micromed Development Corp. · Jul 1994
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
K895502 · Microbio-Medics, Inc. · Dec 1989
HOOD NASAL SPLINT
K890599 · Hood Laboratories · Mar 1989
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
K882244 · Richards Medical Co., Inc. · Jun 1988
'EXMOOR' ATKINS NASAL SPLINT
K864930 · Exmoor Plastics , Ltd. · Mar 1987