510(k) K892379
K892379 is an FDA 510(k) premarket notification submitted by Kuhn Industries for the device "THE POUCH GROIN & ABDOMINAL STRESS AID". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code FSD (Binder, Abdominal), a Class I device regulated under 21 CFR 880.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1989
- Date Received
- April 6, 1989
- 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