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510(k) K871901

ULTRAFLOW by Custom Industries, Inc. — Product Code FZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1987
Date Received
May 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Room
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
Submission Type

Other clearances for product code FZH

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  • K875305 — MODEL UCA / SPEC SYSTEM UCA (January 27, 1988)
  • K770084 — OPERATING ROOM VENTILATOR (February 23, 1977)