The following data is part of a premarket notification filed by Curamedical, Bv with the FDA for Gelita-spon.
Device ID | K051911 |
510k Number | K051911 |
Device Name: | GELITA-SPON |
Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
Applicant | CURAMEDICAL, BV 220 RIVER ROAD Claremont, NH 03743 |
Contact | William Greenrose |
Correspondent | William Greenrose CURAMEDICAL, BV 220 RIVER ROAD Claremont, NH 03743 |
Product Code | KHJ |
CFR Regulation Number | 874.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-14 |
Decision Date | 2005-12-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GELITA-SPON 79021991 3256631 Live/Registered |
GELITA Health GmbH 2006-03-07 |