The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Kerlix Antimicrobial Super Sponge Dressing For Otc Use, Model 6662.
Device ID | K070653 |
510k Number | K070653 |
Device Name: | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 |
Classification | Dressing, Wound, Drug |
Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | Paul W Evans |
Correspondent | Paul W Evans TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2007-03-09 |
Decision Date | 2007-09-12 |
Summary: | summary |