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510(k) K952783

OXBORO-MEDICAL PIN COVERS by Oxboro Medical Intl., Inc. — Product Code LRN

K952783 is an FDA 510(k) premarket notification submitted by Oxboro Medical Intl., Inc. for the device "OXBORO-MEDICAL PIN COVERS". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Oxboro Medical Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
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)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K880028 — OMED DISPOSABLE SCALPEL (January 29, 1988)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)

Other clearances for product code LRN

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K990355 — STAINLESS STEEL SOFT SUTURE WIRE (July 8, 1999)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)

FDA data resources