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510(k) K000904

PENADAPT 10 by Buffalo Filter Co., Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2000
Date Received
March 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by Buffalo Filter Co., Inc.

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  • K983333 — BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 (August 11, 1999)
  • K983364 — BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 (August 11, 1999)
  • K943226 — BUFFALO FILTER REPLACEMENT FILTER #BSPF030 (July 10, 1995)
  • K943227 — BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 (July 7, 1995)
  • K930067 — BUFFALO FILTER SURGICAL MASK (November 30, 1993)
  • K930058 — BUFFALO FILTER REPLACEMENT FILTER #BPTU100 (November 30, 1993)
  • K930062 — BUFFALO FILTER REPLACEMENT FILTER #BST300UL (November 30, 1993)
  • K930064 — BUFFALO FILTER REPLACEMENT FILTER #BCR0030 (November 12, 1993)

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