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510(k) K905393

HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR by Frigitronics, Inc. — Product Code FWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1991
Date Received
November 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Frigitronics, Inc.

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  • K905495 — HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR (April 29, 1991)

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