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510(k) K831665

DISPOSABLE NEEDLE HOLDER by Medcare Products — Product Code KDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medcare Products

  • K841122 — TRACHEOSTOMY CARE TRAY (April 25, 1984)
  • K841124 — DIALYSIS TRAY (April 20, 1984)
  • K841123 — DRESSING CHANGE TRAY (April 17, 1984)
  • K831374 — MED CARE PREP RAZOR (October 4, 1983)
  • K831663 — TISSUE FORCEPS (September 26, 1983)
  • K831664 — PLASTIC THUMB FORCEPS (September 12, 1983)
  • K831661 — DISPOSABLE SCISSORS (August 25, 1983)
  • K831662 — DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (July 19, 1983)
  • K823854 — MEDCARE SUTURE REMOVAL TRAYS (March 31, 1983)
  • K823853 — MEDCARE WOUND CLOSURE TRAY (January 14, 1983)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)