510(k) K821749

AMSCO ENDOSCOPY TABLE by American Sterilizer Co. — Product Code GDC

K821749 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "AMSCO ENDOSCOPY TABLE". The FDA issued a decision of Substantially Equivalent on July 9, 1982. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1982
Date Received
June 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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