The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Goodman Bandage.
| Device ID | K933085 |
| 510k Number | K933085 |
| Device Name: | GOODMAN BANDAGE |
| Classification | Bag, Intestine |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Drew Weaver |
| Correspondent | Drew Weaver MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Product Code | KGY |
| CFR Regulation Number | 878.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1993-12-23 |