The following data is part of a premarket notification filed by Gettig Pharmaceutical Instrument Co. with the FDA for Gettig Guard.
| Device ID | K000455 |
| 510k Number | K000455 |
| Device Name: | GETTIG GUARD |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GETTIG PHARMACEUTICAL INSTRUMENT CO. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | James A Benz |
| Correspondent | James A Benz GETTIG PHARMACEUTICAL INSTRUMENT CO. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-04-19 |