510(k) K812201

PHOTOGRAPHIC EQUIPMENT by Reznik Instruments — Product Code FEM

K812201 is an FDA 510(k) premarket notification submitted by Reznik Instruments for the device "PHOTOGRAPHIC EQUIPMENT". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources)), a Class I device regulated under 21 CFR 876.1500. Reznik Instruments has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
August 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Photographic, For Endoscope (Exclude Light Sources)
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type