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510(k) K830745

ADT DISPOSABLE SCALPEL W/STAINLESS STEEL by Lab Industries, Inc. — Product Code GDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scalpel, One-Piece
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Lab Industries, Inc.

  • K811771 — A.D.T. REUSABLE BONE MARROW NEEDLE (July 10, 1981)

Other clearances for product code GDX

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  • K904505 — CCI CORNEAL SCARIFIER (April 23, 1991)
  • K905380 — 1-CUT ACL GRAFT KNIFE (December 13, 1990)
  • K895682 — VESSEL LOOPS (October 24, 1989)
  • K893033 — MINI-DIAMOND KNIFE (May 26, 1989)
  • K880028 — OMED DISPOSABLE SCALPEL (January 29, 1988)
  • K871894 — KCK INDUSTRIES' SURGICAL INSTRUMENTS (June 23, 1987)
  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (October 24, 1986)