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510(k) K893532

RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 by Medipart Jerry Alexander — Product Code CBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
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)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (January 22, 1990)
  • K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (January 22, 1990)
  • K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (September 26, 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)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)

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