510(k) K880045
K880045 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED AWL/PUNCH, DEPTH GAUGE". The FDA issued a decision of Substantially Equivalent on February 17, 1988. The device falls under product code HWJ (Awl), a Class I device regulated under 21 CFR 888.4540. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1988
- Date Received
- January 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Awl
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type