The following data is part of a premarket notification filed by Aggredyne, Inc. with the FDA for Aggreguide.
| Device ID | K122162 |
| 510k Number | K122162 |
| Device Name: | AGGREGUIDE |
| Classification | System, Automated Platelet Aggregation |
| Applicant | AGGREDYNE, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harbey Knauss |
| Correspondent | J. Harbey Knauss AGGREDYNE, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-20 |
| Decision Date | 2013-12-20 |
| Summary: | summary |