The following data is part of a premarket notification filed by Prism Enterprises, Inc. with the FDA for Mityvac Merlin, Model 10027.
| Device ID | K020447 |
| 510k Number | K020447 |
| Device Name: | MITYVAC MERLIN, MODEL 10027 |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -5600 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -5600 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-11 |
| Decision Date | 2002-04-12 |
| Summary: | summary |