Cleared Traditional

SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)

K882962 · Spembly Medical , Ltd. · General & Plastic Surgery
Aug 1988
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K882962 is an FDA 510(k) clearance for the SERIES 40 & SERIES 42 CRYOPROBES (R SERIES), 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 August 8, 1988, 25 days after receiving the submission on July 14, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K882962 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1988
Decision Date August 08, 1988
Days to Decision 25 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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