510(k) K791859

TECNOL STIRRUPS STRAP by Tecnol New Jersey Wound Care, Inc. — Product Code BWN

K791859 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL STIRRUPS STRAP". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1979
Date Received
September 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type