The following data is part of a premarket notification filed by K.bowmed, Inc. with the FDA for Neonatal Restraint And Comfort Systems.
| Device ID | K943017 |
| 510k Number | K943017 |
| Device Name: | NEONATAL RESTRAINT AND COMFORT SYSTEMS |
| Classification | Holder, Infant Position |
| Applicant | K.BOWMED, INC. P.O. BOX 216 North Wilkesboro, NC 28659 |
| Contact | Karolen C Bowman |
| Correspondent | Karolen C Bowman K.BOWMED, INC. P.O. BOX 216 North Wilkesboro, NC 28659 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-24 |
| Decision Date | 1995-01-19 |