The following data is part of a premarket notification filed by Multigestion (deutschland) Gmbh with the FDA for Multicure(r) S Gel Pad.
Device ID | K950085 |
510k Number | K950085 |
Device Name: | MULTICURE(R) S GEL PAD |
Classification | Cushion, Flotation |
Applicant | MULTIGESTION (DEUTSCHLAND) GMBH LEBUIS/LATOUR DU PIN Saint Victor De Gessieu, FR |
Contact | Francois-xavier Weiss |
Correspondent | Francois-xavier Weiss MULTIGESTION (DEUTSCHLAND) GMBH LEBUIS/LATOUR DU PIN Saint Victor De Gessieu, FR |
Product Code | KIC |
CFR Regulation Number | 890.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-10 |
Decision Date | 1995-07-13 |