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510(k) K870312

WHITE PLUME SURGICAL GAUZE FACE MASK by China National Medicines & Health Prod. I/E Corp. — Product Code FXX

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
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
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)
  • K870315 — WHITE PLUME ABSORBENT BANDAGE (February 24, 1987)
  • K870306 — WHITE PLUME TRIANGULAR BANDAGE (February 24, 1987)
  • K870309 — WHITE PLUME ABSORBENT COTTON WOOL (February 24, 1987)
  • K870314 — WHITE PLUME GAUZE SPONGE (February 24, 1987)
  • K870310 — VSID MEDICAL THREE-FOLDING BED (February 10, 1987)

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