510(k) K895587
K895587 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "CROSS MEDICAL PRODUCT PEDICLE AWL". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code HWJ (Awl), a Class I device regulated under 21 CFR 888.4540. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1990
- Date Received
- September 15, 1989
- 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