Cleared Traditional

K882963 - SPEMBLY MEDICAL 142 CRYO UNIT
(FDA 510(k) Clearance)

K882963 · Spembly Medical , Ltd. · General & Plastic Surgery

Aug 1988

Decision

25d

Days

Class 2

Risk

K882963 is an FDA 510(k) clearance for the SPEMBLY MEDICAL 142 CRYO UNIT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number	K882963 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	—