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510(k) K802726

INSTRUMENTS NONSTERILE & STERILE by Ascep, Inc. — Product Code HAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1980
Date Received
October 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (April 12, 1983)
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  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (January 26, 1981)
  • K791886 — I.V. CARE KIT (October 26, 1979)
  • K791885 — I.V. START SET (October 22, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (October 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (October 17, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (October 17, 1979)

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