The following data is part of a premarket notification filed by Alba Health Care with the FDA for Procedure & Recovery Patient Suit.
| Device ID | K803171 |
| 510k Number | K803171 |
| Device Name: | PROCEDURE & RECOVERY PATIENT SUIT |
| Classification | Gown, Patient |
| Applicant | ALBA HEALTH CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYB |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-15 |
| Decision Date | 1981-03-04 |