The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Towel Drape, Models 4409, 4410.
| Device ID | K012957 |
| 510k Number | K012957 |
| Device Name: | TOWEL DRAPE, MODELS 4409, 4410 |
| Classification | Drape, Surgical |
| Applicant | DYNAREX CORP. 7736 WOODSIDE COURT Maineville, OH 45039 |
| Contact | John Gagliardi |
| Correspondent | John Gagliardi DYNAREX CORP. 7736 WOODSIDE COURT Maineville, OH 45039 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2002-03-06 |
| Summary: | summary |