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510(k) K853574

MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 by Medipart Jerry Alexander — Product Code BYP

K853574 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1985
Date Received
August 26, 1985
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)
  • K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (January 22, 1990)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (September 26, 1989)
  • K893532 — RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 (August 21, 1989)
  • K862783 — MP-XMV DISPOSABLE FACE MASK (August 1, 1986)
  • K862794 — MP-070 RADIOAEROSOL KIT (August 1, 1986)
  • K862795 — MP-070-M RADIOAEROSOL 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)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)

FDA data resources