The following data is part of a premarket notification filed by Dimeda Instrumente Gmbh with the FDA for Dimela Obsterical Forceps, Model 72.1 Xx Xx.
| Device ID | K092827 |
| 510k Number | K092827 |
| Device Name: | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX |
| Classification | Forceps, Obstetrical |
| Applicant | DIMEDA INSTRUMENTE GMBH SCHWARZWALDSTRABE 5 Tuttlingen, DE 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi DIMEDA INSTRUMENTE GMBH SCHWARZWALDSTRABE 5 Tuttlingen, DE 78532 |
| Product Code | HDA |
| CFR Regulation Number | 884.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2010-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842331102288 | K092827 | 000 |
| 00842331102158 | K092827 | 000 |
| 00842331102165 | K092827 | 000 |
| 00842331102172 | K092827 | 000 |
| 00842331102189 | K092827 | 000 |
| 00842331102196 | K092827 | 000 |
| 00842331102202 | K092827 | 000 |
| 00842331102219 | K092827 | 000 |
| 00842331102226 | K092827 | 000 |
| 00842331102233 | K092827 | 000 |
| 00842331102240 | K092827 | 000 |
| 00842331102257 | K092827 | 000 |
| 00842331102264 | K092827 | 000 |
| 00842331102271 | K092827 | 000 |
| 00842331102141 | K092827 | 000 |