The following data is part of a premarket notification filed by Safeguard Medical Products, Inc. with the FDA for Sologuard Locking Plus Syringe.
| Device ID | K993609 |
| 510k Number | K993609 |
| Device Name: | SOLOGUARD LOCKING PLUS SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | SAFEGUARD MEDICAL PRODUCTS, INC. 52 DRAGON CT. Woburn, MA 01801 |
| Contact | Patrick Grant |
| Correspondent | Patrick Grant SAFEGUARD MEDICAL PRODUCTS, INC. 52 DRAGON CT. Woburn, MA 01801 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-25 |
| Decision Date | 2000-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 5999039513757 | K993609 | 000 |
| 5999039501495 | K993609 | 000 |
| 5999039501464 | K993609 | 000 |
| 5999039501433 | K993609 | 000 |
| 5999039501402 | K993609 | 000 |
| 5999039501372 | K993609 | 000 |
| 5999039500177 | K993609 | 000 |
| 5999039500115 | K993609 | 000 |
| 5999039500085 | K993609 | 000 |
| 5999039500023 | K993609 | 000 |
| 05999039511999 | K993609 | 000 |
| 5999039501853 | K993609 | 000 |
| 5999039501884 | K993609 | 000 |
| 5999039512477 | K993609 | 000 |
| 5999039512439 | K993609 | 000 |
| 5999039512392 | K993609 | 000 |
| 5999039512354 | K993609 | 000 |
| 5999039512316 | K993609 | 000 |
| 5999039512231 | K993609 | 000 |
| 5999039512156 | K993609 | 000 |
| 5999039512118 | K993609 | 000 |
| 5999039510633 | K993609 | 000 |
| 5999039501914 | K993609 | 000 |
| 05999039514471 | K993609 | 000 |