The following data is part of a premarket notification filed by North Eos Industries, Inc. with the FDA for Eos Brand Disposable Cyto/cervical Sampler.
| Device ID | K963685 |
| 510k Number | K963685 |
| Device Name: | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER |
| Classification | Spatula, Cervical, Cytological |
| Applicant | NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH Taichung Hsien 423, TW |
| Contact | Sara Chen |
| Correspondent | Sara Chen NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH Taichung Hsien 423, TW |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712568360279 | K963685 | 000 |
| 04712568360262 | K963685 | 000 |
| 04712568360255 | K963685 | 000 |