The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Pfizer Hospital Products Group Acl Drill Guide.
| Device ID | K881378 |
| 510k Number | K881378 |
| Device Name: | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE |
| Classification | Guide, Drill, Ligament |
| Applicant | PFIZER, INC. EASTERN POINT RD. Groton, CT 06340 |
| Contact | Joseph E Laptewicz |
| Correspondent | Joseph E Laptewicz PFIZER, INC. EASTERN POINT RD. Groton, CT 06340 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-06-17 |