510(k) K903969

SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET by Karlin Technology, Inc. — Product Code GAD

K903969 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
August 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type