The following data is part of a premarket notification filed by R.o.s.t. Medical Development, Inc. with the FDA for Umbilical Clamp And Cutter.
| Device ID | K963428 |
| 510k Number | K963428 |
| Device Name: | UMBILICAL CLAMP AND CUTTER |
| Classification | Clamp, Umbilical |
| Applicant | R.O.S.T. MEDICAL DEVELOPMENT, INC. 11800 28TH ST., NORTH St. Petersburg, FL 33716 |
| Contact | Howard K Mann |
| Correspondent | Howard K Mann R.O.S.T. MEDICAL DEVELOPMENT, INC. 11800 28TH ST., NORTH St. Petersburg, FL 33716 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-04-01 |