The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Instaclear Lens Cleaner.
| Device ID | K152531 |
| 510k Number | K152531 |
| Device Name: | InstaClear Lens Cleaner |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925040021 | K152531 | 000 |
| 00821925039896 | K152531 | 000 |
| 00821925039889 | K152531 | 000 |
| 00821925040045 | K152531 | 000 |
| 00821925040038 | K152531 | 000 |
| 00821925041455 | K152531 | 000 |
| 00821925041448 | K152531 | 000 |
| 00821925041431 | K152531 | 000 |
| 00821925041424 | K152531 | 000 |
| 00821925041417 | K152531 | 000 |
| 00821925041400 | K152531 | 000 |
| 00821925039902 | K152531 | 000 |
| 00821925039919 | K152531 | 000 |
| 00821925040014 | K152531 | 000 |
| 00821925040007 | K152531 | 000 |
| 00821925039995 | K152531 | 000 |
| 00821925039988 | K152531 | 000 |
| 00821925039971 | K152531 | 000 |
| 00821925039964 | K152531 | 000 |
| 00821925039957 | K152531 | 000 |
| 00821925039940 | K152531 | 000 |
| 00821925039933 | K152531 | 000 |
| 00821925039926 | K152531 | 000 |
| 00821925041394 | K152531 | 000 |