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510(k) K790933

MOUTHPIECE M-187 by Mem Medical, Inc. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1979
Date Received
May 15, 1979
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 Mem Medical, Inc.

  • K791905 — IMV W/BAG & TUBING #M-508 (October 9, 1979)
  • K791908 — RETARD VALVE 3-STACK #M-514 (October 9, 1979)
  • K791904 — IMV W/BAG & HOSES #M-509 (October 9, 1979)
  • K791907 — RETARD VALVE 3-STACK #M-515 (October 9, 1979)
  • K791910 — THREE LITER BAG #M-512 (October 9, 1979)
  • K791909 — IMV BUSHING #M-513 (October 9, 1979)
  • K791911 — FALL-SAFE IMV #M-511 (October 9, 1979)
  • K791913 — IMV MANIFOLD #M-506 (October 9, 1979)
  • K791912 — IMV FOR MONITORING #M-510 (October 9, 1979)
  • K791906 — IMV W/BAG #M-507 (October 9, 1979)

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)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)