Cleared Traditional

SURGICAL SEALANT APPLICATOR

K883338 · Micromedics, Inc. · General Hospital
Aug 1988
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K883338 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 23, 1988, 14 days after receiving the submission on August 9, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K883338 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date August 23, 1988
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960