The following data is part of a premarket notification filed by Milliken Healthcare Products, Llc with the FDA for Interdry Silver.
Device ID | K110715 |
510k Number | K110715 |
Device Name: | INTERDRY SILVER |
Classification | Fiber, Medical, Absorbent |
Applicant | MILLIKEN HEALTHCARE PRODUCTS, LLC 920 MILLIKEN ROAD Spartanburg, SC 29303 |
Contact | Brian J Lindsay |
Correspondent | Brian J Lindsay MILLIKEN HEALTHCARE PRODUCTS, LLC 920 MILLIKEN ROAD Spartanburg, SC 29303 |
Product Code | FRL |
CFR Regulation Number | 880.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-15 |
Decision Date | 2011-11-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00311701069938 | K110715 | 000 |
00311701069426 | K110715 | 000 |
00311701068726 | K110715 | 000 |