The following data is part of a premarket notification filed by Pro-safe Professional Linens, Inc. with the FDA for Aprons, Scrubs Slacks & Tops, Patient Drape.
| Device ID | K891212 |
| 510k Number | K891212 |
| Device Name: | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE |
| Classification | Suit, Surgical |
| Applicant | PRO-SAFE PROFESSIONAL LINENS, INC. 304 W. MAIN ST. Grand Junction, CO 81501 |
| Contact | Scott Kafka |
| Correspondent | Scott Kafka PRO-SAFE PROFESSIONAL LINENS, INC. 304 W. MAIN ST. Grand Junction, CO 81501 |
| Product Code | FXO |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-07 |
| Decision Date | 1989-04-14 |