The following data is part of a premarket notification filed by Pro-safe Professional Linens, Inc. with the FDA for Fast Wrap #m 101.
| Device ID | K891215 |
| 510k Number | K891215 |
| Device Name: | FAST WRAP #M 101 |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-07 |
| Decision Date | 1989-04-14 |