510(k) K935356

CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES by Amsco American Sterilizer Co. — Product Code FWW

K935356 is an FDA 510(k) premarket notification submitted by Amsco American Sterilizer Co. for the device "CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
November 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Pneumatic
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type