The following data is part of a premarket notification filed by Noetix, Inc. with the FDA for Noetix(r) Surgical Extraction(tm) System.
| Device ID | K881635 |
| 510k Number | K881635 |
| Device Name: | NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | NOETIX, INC. 5602 ELMWOOD AVE., STE.122, ELMWOOD PARK Indianapolis, IN 46203 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark NOETIX, INC. 5602 ELMWOOD AVE., STE.122, ELMWOOD PARK Indianapolis, IN 46203 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-07-01 |