The following data is part of a premarket notification filed by Oxboro Medical Intl., Inc. with the FDA for Omed Disposable Scalpel.
| Device ID | K880028 |
| 510k Number | K880028 |
| Device Name: | OMED DISPOSABLE SCALPEL |
| Classification | Scalpel, One-piece |
| Applicant | OXBORO MEDICAL INTL., INC. 9635 GIRARD AVE SOUTH Bloomington, MN 55431 |
| Contact | Kevin P Maxwell |
| Correspondent | Kevin P Maxwell OXBORO MEDICAL INTL., INC. 9635 GIRARD AVE SOUTH Bloomington, MN 55431 |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-01-29 |