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510(k) K952616

MICROTIME by Westmed Intl. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
June 6, 1995
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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  • K953506 — WESTMED RESPIRATORY LUER ADAPTOR (September 15, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K924944 — INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (July 2, 1993)
  • K925173 — BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (January 15, 1993)

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