The following data is part of a premarket notification filed by Cross Medical Products, Inc. with the FDA for Cross Medical Product Pedicle Awl.
| Device ID | K895587 |
| 510k Number | K895587 |
| Device Name: | CROSS MEDICAL PRODUCT PEDICLE AWL |
| Classification | Awl |
| Applicant | CROSS MEDICAL PRODUCTS, INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | Bromm, R.n. |
| Correspondent | Bromm, R.n. CROSS MEDICAL PRODUCTS, INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HWJ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1990-01-04 |