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510(k) K913303

LAP SPONGES, MODIFIED by Carwild Corp. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1992
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Carwild Corp.

  • K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (July 23, 1992)
  • K833688 — SUTURE REMOVAL KITS STERILE (May 31, 1984)
  • K791872 — LAP SPONGES (November 13, 1979)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)
  • K791871 — NEUROLOGICAL SPONGES (PATTIES) (November 5, 1979)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953057 — CYLINDRICAL SPONGE (September 14, 1995)