The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Softrelease.
| Device ID | K041018 |
| 510k Number | K041018 |
| Device Name: | DRG SOFTRELEASE |
| Classification | Spatula, Cervical, Cytological |
| Applicant | DOCTOR'S RESEARCH GROUP, INC. 50 ALTAIR AVE. Plymouth, CT 06782 |
| Contact | Edward H Goldman |
| Correspondent | Edward H Goldman DOCTOR'S RESEARCH GROUP, INC. 50 ALTAIR AVE. Plymouth, CT 06782 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-20 |
| Decision Date | 2004-10-18 |
| Summary: | summary |