The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Dressing Change Kit.
| Device ID | K910363 |
| 510k Number | K910363 |
| Device Name: | MEGA DRESSING CHANGE KIT |
| Classification | Wound Dressing Kit |
| 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 | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-03-28 |