The following data is part of a premarket notification filed by Scandinavian Health Limited with the FDA for Whisperject Autoinjector.
| Device ID | K141384 |
| 510k Number | K141384 |
| Device Name: | WHISPERJECT AUTOINJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | SCANDINAVIAN HEALTH LIMITED #588 JIM MORAN BLVD Deerfield Beach, FL 33442 |
| Contact | James Haynes |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00303789300324 | K141384 | 000 |