FDA 510(k), K934261, ERBOKRYO CA CRYOSURGICAL SYSTEM

510(K) Number: K934261
Device Name: ERBOKRYO CA CRYOSURGICAL SYSTEM
Manufacturer: ORALIE ENOS
Device Classification Name: Unit, Cryosurgical, Accessories
Regulation Number: GEH
Classification Product Code: KXA
Date Received: 08/31/1993
Decision Date: 04/26/1994
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

• Total Pages: 68
• Fully Redacted Pages: 16
• Content Pages: 52 (Total pages minus fully redacted pages)