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510(k) K964047

CRYOSIL SILICONE GEL SHEETING by Biodermis Corp. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1997
Date Received
October 9, 1996
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 Biodermis Corp.

  • K003948 — EPI-DERM SILICONE GEL SHEETING (January 29, 2001)
  • K992146 — SCARAID SILICONE GEL SHEETING (July 30, 1999)
  • K991604 — EPI-FOAM SILICONE SHEETING (June 9, 1999)
  • K942156 — EPI-DERM SILICONE GEL SHEETING (June 13, 1994)

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