510(k) K883760

STORZ MODEL 62 ENT CAMERA SYSTEM by Storz Instrument Co. — Product Code FWL

K883760 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ MODEL 62 ENT CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 1988. The device falls under product code FWL (Camera, Cine, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1988
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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