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510(k) K935540

PARI-MASTER MODIFICATION by Pari Holding Co. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1995
Date Received
November 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Pari Holding Co.

  • K002862 — PRONEB ULTRA MODEL NUMBER 85B0100 (March 13, 2001)
  • K983308 — RC CORNET, MODEL #44F50 (June 4, 1999)
  • K972042 — PARI PEP THERAPY SYSTEM (August 5, 1997)
  • K963924 — LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 (December 10, 1996)
  • K962072 — PRONEB TURBO COMPRESSOR MODEL 38V0200 (August 21, 1996)
  • K960675 — WALKHALER PORTABLE COMPRESSOR MODEL 45F70 (May 17, 1996)
  • K944152 — PARI BABY (November 18, 1994)

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