510(k) K811717

GATOR DRAPES by The Anspach Effort, Inc. — Product Code KQM

K811717 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "GATOR DRAPES". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Surgical And Accessories
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type