The following data is part of a premarket notification filed by Engineering, Inc. with the FDA for Modified Servo Syringe.
| Device ID | K881521 |
| 510k Number | K881521 |
| Device Name: | MODIFIED SERVO SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ENGINEERING, INC. 1705 S.W. 4TH ST. Fort Lauderdale, FL 33312 |
| Contact | Kevin W Smith |
| Correspondent | Kevin W Smith ENGINEERING, INC. 1705 S.W. 4TH ST. Fort Lauderdale, FL 33312 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-05-31 |