510(k) K760772

DISPOSABLE ABDOMINAL BINDER by Tecnol New Jersey Wound Care, Inc. — Product Code FSD

K760772 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "DISPOSABLE ABDOMINAL BINDER". The FDA issued a decision of Substantially Equivalent on November 3, 1976. The device falls under product code FSD (Binder, Abdominal), a Class I device regulated under 21 CFR 880.5160. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1976
Date Received
October 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Binder, Abdominal
Device Class
Class I
Regulation Number
880.5160
Review Panel
HO
Submission Type