The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Gram-ma Neonatal Sc.
| Device ID | K853475 |
| 510k Number | K853475 |
| Device Name: | GRAM-MA NEONATAL SC |
| Classification | Scale, Patient |
| Applicant | KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Contact | Steve Becsi |
| Correspondent | Steve Becsi KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Product Code | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-09-05 |