The following data is part of a premarket notification filed by North Eos Industries, Inc. with the FDA for Eos Brand Disposable Vaginal Speculum-eosspec.
| Device ID | K963377 |
| 510k Number | K963377 |
| Device Name: | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. TUNG-SHIH Taichung Hsien, TW |
| Contact | Sara Chen |
| Correspondent | Sara Chen NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. TUNG-SHIH Taichung Hsien, TW |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1996-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712568360248 | K963377 | 000 |
| 04712568360026 | K963377 | 000 |
| 04712568360033 | K963377 | 000 |
| 04712568360040 | K963377 | 000 |
| 04712568360057 | K963377 | 000 |
| 04712568360064 | K963377 | 000 |
| 04712568360071 | K963377 | 000 |
| 04712568360088 | K963377 | 000 |
| 04712568360095 | K963377 | 000 |
| 04712568360101 | K963377 | 000 |
| 04712568360118 | K963377 | 000 |
| 04712568360125 | K963377 | 000 |
| 04712568360132 | K963377 | 000 |
| 04712568360149 | K963377 | 000 |
| 04712568360156 | K963377 | 000 |
| 04712568360163 | K963377 | 000 |
| 04712568360224 | K963377 | 000 |
| 04712568360231 | K963377 | 000 |
| 04712568360019 | K963377 | 000 |