Cleared Traditional

130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY

K882568 · Spembly Medical , Ltd. · General & Plastic Surgery
Sep 1988
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K882568 is an FDA 510(k) clearance for the 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on September 27, 1988, 97 days after receiving the submission on June 22, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K882568 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1988
Decision Date September 27, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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