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510(k) K933327

HISTOFREEZER by Solarcare, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1993
Date Received
July 8, 1993
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 Solarcare, Inc.

  • K934775 — STC COCAINE METABOLITE EIA (July 14, 1995)
  • K944372 — STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (February 8, 1995)
  • K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (October 27, 1994)
  • K941497 — SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (May 24, 1994)
  • K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (December 7, 1993)

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