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510(k) K882883

C-MASK(FLAT) by Promedica Products, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1988
Date Received
July 11, 1988
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 Promedica Products, Inc.

  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K913102 — PETERS CARDIONYL(TM) SUTURE (August 3, 1992)
  • K892768 — PATIENT EXAMINATION GLOVES (POLY) (June 14, 1989)
  • K883412 — THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) (February 8, 1989)
  • K882882 — C-MASK (August 10, 1988)

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