The following data is part of a premarket notification filed by Henke-sass Wolf, Gmbh. with the FDA for Henke- Sass, Wolf Piston Syringe (norm-jet).
| Device ID | K101547 |
| 510k Number | K101547 |
| Device Name: | HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) |
| Classification | Syringe, Piston |
| Applicant | HENKE-SASS WOLF, GMBH. 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard HENKE-SASS WOLF, GMBH. 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-11-22 |
| Summary: | summary |