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510(k) K870314

WHITE PLUME GAUZE SPONGE by China National Medicines & Health Prod. I/E Corp. — Product Code EFQ

K870314 is an FDA 510(k) premarket notification submitted by China National Medicines & Health Prod. I/E Corp. for the device "WHITE PLUME GAUZE SPONGE". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. China National Medicines & Health Prod. I/E Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1987
Date Received
January 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by China National Medicines & Health Prod. I/E Corp.

  • K902324 — TP AND DESIGN, CONDOM (March 29, 1991)
  • K893351 — LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) (November 17, 1989)
  • K892916 — PATIENT EXAMINATION GLOVES (LATEX) (July 14, 1989)
  • K891365 — LATEX EXAMINATION GLOVES, NON-STERILE (April 26, 1989)
  • K870308 — WHITE PLUME ABSORBENT GAUZE (February 24, 1987)
  • K870306 — WHITE PLUME TRIANGULAR BANDAGE (February 24, 1987)
  • K870309 — WHITE PLUME ABSORBENT COTTON WOOL (February 24, 1987)
  • K870312 — WHITE PLUME SURGICAL GAUZE FACE MASK (February 24, 1987)
  • K870315 — WHITE PLUME ABSORBENT BANDAGE (February 24, 1987)
  • K870310 — VSID MEDICAL THREE-FOLDING BED (February 10, 1987)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources