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510(k) K810720

I.M. SCALPEL HANDLE by Instrument Makar, Inc. — Product Code GDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1981
Date Received
March 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code GDZ

  • K091462 — SPECTRA MEDICAL SAFETY SCAPEL (December 15, 2009)
  • K890242 — SCALPEL HANDLE (January 27, 1989)
  • K884512 — BEAVER(R) HANDLE (November 17, 1988)
  • K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (October 24, 1986)
  • K863808 — THE S. CORDERO STYLUS (October 14, 1986)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K852711 — SCALPEL HANDLE #3 SS 410 OR 420 (July 15, 1985)
  • K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (June 20, 1985)