The following data is part of a premarket notification filed by Proa Medical, Inc. with the FDA for Brella-spec(tm) Vaginal Speculum.
| Device ID | K133857 |
| 510k Number | K133857 |
| Device Name: | BRELLA-SPEC(TM) VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | PROA MEDICAL, INC. 2512 Artesia Blvd Ste 305C Redondo Beach, CA 90278 |
| Contact | Victoria Nadershahi |
| Correspondent | Victoria Nadershahi PROA MEDICAL, INC. 2512 Artesia Blvd Ste 305C Redondo Beach, CA 90278 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-04-28 |
| Summary: | summary |