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510(k) K761297

MOUTHPIECE SEAL by Oem Medical Div. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1977
Date Received
December 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Breathing
Device Class
Class I
Regulation Number
868.5620
Review Panel
AN
Submission Type

Other clearances by Oem Medical Div.

  • K924570 — OEM MULTI-VAC POWERED SUCTION PUMP (August 5, 1993)
  • K925893 — OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT (March 12, 1993)
  • K922748 — GUEDEL AIRWAY (July 10, 1992)
  • K811855 — SKIN SCRUB KITS (July 31, 1981)

Other clearances for product code BYP

  • K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (March 12, 1996)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863049 — INHALATION AID (October 15, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)