Cleared Traditional

SURGICAL SEALANT DISPENSER (SSD)

K881020 · Micromedics, Inc. · General Hospital
Mar 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K881020 is an FDA 510(k) clearance for the SURGICAL SEALANT DISPENSER (SSD), 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 March 25, 1988, 15 days after receiving the submission on March 10, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K881020 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1988
Decision Date March 25, 1988
Days to Decision 15 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