The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Modification To Hemcon Bandage And Hemcon Bandage Otc.
Device ID | K072486 |
510k Number | K072486 |
Device Name: | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC |
Classification | Dressing, Wound, Drug |
Applicant | HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
Contact | Kevin Hawkins |
Correspondent | Kevin Hawkins HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
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 | 2007-09-04 |
Decision Date | 2008-08-06 |
Summary: | summary |