The following data is part of a premarket notification filed by Vygon S A with the FDA for Boussignac C.p.a.p. Device.
| Device ID | K013884 |
| 510k Number | K013884 |
| Device Name: | BOUSSIGNAC C.P.A.P. DEVICE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | VYGON S A 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard VYGON S A 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2003-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 33660812115866 | K013884 | 000 |
| 38498840012131 | K013884 | 000 |
| 30849884002417 | K013884 | 000 |
| 30849884002400 | K013884 | 000 |
| 30849884001403 | K013884 | 000 |
| 30849884001199 | K013884 | 000 |
| 30849884002431 | K013884 | 000 |
| 30849884002424 | K013884 | 000 |
| 53660812032846 | K013884 | 000 |