The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Euro-med Clear-vue Disposable Vaginal Speculum.
| Device ID | K882605 |
| 510k Number | K882605 |
| Device Name: | EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-09-15 |