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510(k) K983308

RC CORNET, MODEL #44F50 by Pari Holding Co. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1999
Date Received
September 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by Pari Holding Co.

  • K002862 — PRONEB ULTRA MODEL NUMBER 85B0100 (March 13, 2001)
  • 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)
  • K935540 — PARI-MASTER MODIFICATION (March 17, 1995)
  • K944152 — PARI BABY (November 18, 1994)

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