The following data is part of a premarket notification filed by Gettig Pharmaceutical Instrument Co. with the FDA for Gettig Styrl-ject Delivery System.
| Device ID | K972285 |
| 510k Number | K972285 |
| Device Name: | GETTIG STYRL-JECT DELIVERY SYSTEM |
| Classification | Syringe, Cartridge |
| Applicant | GETTIG PHARMACEUTICAL INSTRUMENT CO. 1 STREAM SIDE PL. WEST Spring Mills, PA 16875 -0085 |
| Contact | Kevin Fee |
| Correspondent | Kevin Fee GETTIG PHARMACEUTICAL INSTRUMENT CO. 1 STREAM SIDE PL. WEST Spring Mills, PA 16875 -0085 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-19 |
| Decision Date | 1997-09-11 |
| Summary: | summary |