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510(k) K862788

MP-4400 MOUTHPIECE-FLANGE SEAL by Medipart Jerry Alexander — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 23, 1986
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 Medipart Jerry Alexander

  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)
  • K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (February 1, 1990)
  • K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (January 22, 1990)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (January 22, 1990)
  • K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (September 26, 1989)
  • K893532 — RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 (August 21, 1989)
  • K862785 — MP-1204 DISPOSABLE BACTERIA FILTER (August 1, 1986)
  • K862787 — MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER (August 1, 1986)
  • K862791 — MP-30XM-IE FACE MASK AND FILTER KIT (August 1, 1986)

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)
  • 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)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)