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510(k) K952689

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK by Owens-Brigam Medical Co. — Product Code BSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
June 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Owens-Brigam Medical Co.

  • K963848 — MANUAL RESUSCITATOR (July 7, 1997)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)
  • K932014 — AMBU DISPOSABLE FACE MASK (June 22, 1993)