The following data is part of a premarket notification filed by Regen Lab Sa with the FDA for Regen Spray Applicator,.
| Device ID | K122122 |
| 510k Number | K122122 |
| Device Name: | REGEN SPRAY APPLICATOR, |
| Classification | Syringe, Piston |
| Applicant | REGEN LAB SA 3428 AVENUE MARCIL Montreal, CA H4a 2z3 |
| Contact | Guy Fortier |
| Correspondent | Guy Fortier REGEN LAB SA 3428 AVENUE MARCIL Montreal, CA H4a 2z3 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2012-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08500331310110 | K122122 | 000 |