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510(k) K880028

OMED DISPOSABLE SCALPEL by Oxboro Medical Intl., Inc. — Product Code GDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
January 5, 1988
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 Oxboro Medical Intl., Inc.

  • K953068 — OXBORO-MEDICAL FOAM INSTRUMENT HOLDER (January 23, 1996)
  • K952787 — FOAM INSTRUMENT GUARD (December 28, 1995)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)

Other clearances for product code GDX

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  • K921167 — ULTRABLADE (July 30, 1992)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • 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)
  • K871894 — KCK INDUSTRIES' SURGICAL INSTRUMENTS (June 23, 1987)
  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (October 24, 1986)
  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (September 2, 1986)