The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Vaginal Speculum - Disposable.
| Device ID | K841909 |
| 510k Number | K841909 |
| Device Name: | VAGINAL SPECULUM - DISPOSABLE |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | GALENICA ENTERPRISES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-09 |
| Decision Date | 1984-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50888937013653 | K841909 | 000 |
| 40888937012420 | K841909 | 000 |
| 40888937012437 | K841909 | 000 |
| 40888937012444 | K841909 | 000 |
| 40888937012451 | K841909 | 000 |
| 20612479101733 | K841909 | 000 |
| 20612479101757 | K841909 | 000 |
| 20612479101771 | K841909 | 000 |
| 50888937010102 | K841909 | 000 |
| 40888937010112 | K841909 | 000 |
| 20888937010125 | K841909 | 000 |
| 40888937010136 | K841909 | 000 |
| 40888937010143 | K841909 | 000 |
| 20888937010156 | K841909 | 000 |
| 50888937010164 | K841909 | 000 |
| 50888937010171 | K841909 | 000 |
| 50888937010188 | K841909 | 000 |
| 40888937012413 | K841909 | 000 |