FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CS-76 AND/OR CRYOCARE I

K Number: K760742 · Decision Nov 3, 1976
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
9
Review Days
34

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Basic Information

Device Name
CS-76 AND/OR CRYOCARE I
K Number
K760742
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4350
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Frigitronics of Connecticut, Inc.
Date Received
September 30, 1976
Decision Date
November 3, 1976
Product Code
GEH
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEH Unit, Cryosurgical, Accessories

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Other Clearances by Frigitronics of Connecticut, Inc.

K Number Device Name
K891282 MIC-100 WITH CRYOPROBES
K872362 FRIGITRONICS ACC-1000 CAPSULE CUTTER
K853308 KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
K834577 I/A PROBE LINES
K840536 CRYO SURG 5900
K834437 KEATES IRRIGATION/ASPIRATION/VITREOUS
K822599 KEATES I/A SYSTEM FRIGITRONICS 4000
K811390 CCS100 CRYOSURGICAL SYSTEM