The following data is part of a premarket notification filed by Medcom Laundry Service, Inc. with the FDA for Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack.
| Device ID | K981073 |
| 510k Number | K981073 |
| Device Name: | MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK |
| Classification | Gown, Surgical |
| Applicant | MEDCOM LAUNDRY SERVICE, INC. 517 NORTH LINK LANE, UNIT D Fort Collins, CO 80524 |
| Contact | Gary Vandriel |
| Correspondent | Gary Vandriel MEDCOM LAUNDRY SERVICE, INC. 517 NORTH LINK LANE, UNIT D Fort Collins, CO 80524 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-24 |
| Decision Date | 1998-05-15 |