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510(k) K963067

SOF. PRESS EPC 51 SYSTEM by Gaymar Industries, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1997
Date Received
August 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

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  • K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (August 9, 1996)
  • K942881 — TC 3000 (May 23, 1995)
  • K930345 — TC2000 POWER UNIT AND ACCESSORIES (August 6, 1993)
  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K914851 — CLA-1400 SYSTEM (November 13, 1991)
  • K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSES (July 30, 1991)

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