510(k) K965028
K965028 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "ACUMED SUTURE WASHER". The FDA issued a decision of Substantially Equivalent on March 17, 1997. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Acu Med, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1997
- Date Received
- December 17, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type