The following data is part of a premarket notification filed by Safetech Intl., Inc. with the FDA for Doyle Extractor.
| Device ID | K955748 |
| 510k Number | K955748 |
| Device Name: | DOYLE EXTRACTOR |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SAFETECH INTL., INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane Minear |
| Correspondent | Diane Minear SAFETECH INTL., INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-03-14 |
| Summary: | summary |