510(k) K760772
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