The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Laceration Kit.
| Device ID | K910368 |
| 510k Number | K910368 |
| Device Name: | MEGA LACERATION KIT |
| Classification | General Surgery Tray |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| Contact | Ellen Joy |
| Correspondent | Ellen Joy MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-03-18 |