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510(k) K002862

PRONEB ULTRA MODEL NUMBER 85B0100 by Pari Holding Co. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2001
Date Received
September 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

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  • 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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