Cleared Traditional

CPR LAP SPONGES

K960236 · Custom Pack Reliability · General & Plastic Surgery
Mar 1996
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K960236 is an FDA 510(k) clearance for the CPR LAP SPONGES, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on March 28, 1996, 72 days after receiving the submission on January 16, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number K960236 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date March 28, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GDY — Gauze/sponge, Internal, X-ray Detectable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4450

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