The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Barraquer Oval Speculum-various Sizes.
| Device ID | K772370 |
| 510k Number | K772370 |
| Device Name: | BARRAQUER OVAL SPECULUM-VARIOUS SIZES |
| Classification | Speculum, Ent |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EPY |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-27 |
| Decision Date | 1978-01-17 |