The following data is part of a premarket notification filed by Medical Specialties Intl., Inc. with the FDA for Control Syringe.
| Device ID | K972655 |
| 510k Number | K972655 |
| Device Name: | CONTROL SYRINGE |
| Classification | System, X-ray, Angiographic |
| Applicant | MEDICAL SPECIALTIES INTL., INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
| Contact | Larry G Junker |
| Correspondent | Larry G Junker MEDICAL SPECIALTIES INTL., INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1997-11-04 |