The following data is part of a premarket notification filed by Poamax L.l.c. with the FDA for Beraclamp, Model Bc-1.
| Device ID | K990045 |
| 510k Number | K990045 |
| Device Name: | BERACLAMP, MODEL BC-1 |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | POAMAX L.L.C. 17 ALPHUS ST. Poguoson, VA 23662 |
| Contact | Michael J Palmer |
| Correspondent | Michael J Palmer POAMAX L.L.C. 17 ALPHUS ST. Poguoson, VA 23662 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-05-24 |