The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Umbilical Cord Lamp, Models 6833 And 6833-b.
| Device ID | K012917 |
| 510k Number | K012917 |
| Device Name: | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B |
| Classification | Clamp, Umbilical |
| 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 | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-30 |
| Decision Date | 2001-11-28 |
| Summary: | summary |