| K-number | K853475 |
| Device name | GRAM-MA NEONATAL SC |
| Applicant | Kentec Medical, Inc. |
| Product code | FRW |
| Device class | Class I |
| Decision date | Sep 5, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 880.2720 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov