The following data is part of a premarket notification filed by David Craig Marketing, Inc. with the FDA for Steri-stat Reusable Syringe.
| Device ID | K910667 |
| 510k Number | K910667 |
| Device Name: | STERI-STAT REUSABLE SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DAVID CRAIG MARKETING, INC. P.O. BOX 89 Martinsville, NJ 08836 |
| Contact | George V Mastapeter |
| Correspondent | George V Mastapeter DAVID CRAIG MARKETING, INC. P.O. BOX 89 Martinsville, NJ 08836 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-09-04 |