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510(k) K955320

PROTEC COTTON PADDING BANDAGE by Derivadas Degasa S.A. DE C.V. — Product Code LGF

K955320 is an FDA 510(k) premarket notification submitted by Derivadas Degasa S.A. DE C.V. for the device "PROTEC COTTON PADDING BANDAGE". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Derivadas Degasa S.A. DE C.V. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
November 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
Submission Type

Other clearances by Derivadas Degasa S.A. DE C.V.

  • K961773 — PROTEC STERILE GAUZE SPONGE (July 29, 1996)
  • K960093 — PROTEC ROLL GAUZE (March 25, 1996)

Other clearances for product code LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)
  • K874880 — COLORED CASTING TAPE CARAGLAS(TM GREEN (December 30, 1987)

FDA data resources