The following data is part of a premarket notification filed by Medical Sterile Products, Inc. with the FDA for Msp M/k Blade.
| Device ID | K993122 |
| 510k Number | K993122 |
| Device Name: | MSP M/K BLADE |
| Classification | Keratome, Ac-powered |
| Applicant | MEDICAL STERILE PRODUCTS, INC. RD. 413, KM. 0.2 Rincon, PR 00677 |
| Contact | Gary C Dionne |
| Correspondent | Gary C Dionne MEDICAL STERILE PRODUCTS, INC. RD. 413, KM. 0.2 Rincon, PR 00677 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 2000-03-16 |
| Summary: | summary |