The following data is part of a premarket notification filed by Dynatech Medical Products with the FDA for Dynasty Impervious Isolation J-suit.
| Device ID | K923188 |
| 510k Number | K923188 |
| Device Name: | DYNASTY IMPERVIOUS ISOLATION J-SUIT |
| Classification | Gown, Isolation, Surgical |
| Applicant | DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Contact | Mitchell Davis |
| Correspondent | Mitchell Davis DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1993-01-29 |