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510(k) K973686

ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM by Endocare, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
September 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Endocare, Inc.

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  • K032333 — CRYOCARE CS SURGICAL SYSTEM (August 12, 2003)
  • K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (December 5, 2002)
  • K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (June 6, 2002)
  • K020082 — ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS (February 5, 2002)
  • K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
  • K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)

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