The following data is part of a premarket notification filed by Stryker with the FDA for Precision S 4k Sinuscope.
| Device ID | K191102 |
| 510k Number | K191102 |
| Device Name: | Precision S 4K Sinuscope |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Jessie Duong |
| Correspondent | Jessie Duong Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327412192 | K191102 | 000 |
| 07613327412086 | K191102 | 000 |
| 07613327412079 | K191102 | 000 |
| 07613327412062 | K191102 | 000 |
| 07613327412055 | K191102 | 000 |
| 07613327412048 | K191102 | 000 |
| 07613327412031 | K191102 | 000 |
| 07613327412024 | K191102 | 000 |
| 07613327412017 | K191102 | 000 |
| 07613327412093 | K191102 | 000 |
| 07613327412109 | K191102 | 000 |
| 07613327412185 | K191102 | 000 |
| 07613327412178 | K191102 | 000 |
| 07613327412161 | K191102 | 000 |
| 07613327412154 | K191102 | 000 |
| 07613327412147 | K191102 | 000 |
| 07613327412130 | K191102 | 000 |
| 07613327412123 | K191102 | 000 |
| 07613327412116 | K191102 | 000 |
| 07613327412000 | K191102 | 000 |