The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Flight Sock.
Device ID | K040353 |
510k Number | K040353 |
Device Name: | FLIGHT SOCK |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR. Norcross, GA 30092 |
Contact | Kathleen J Harris |
Correspondent | Kathleen J Harris SSL AMERICAS, INC. 3585 ENGINEERING DR. Norcross, GA 30092 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-12 |
Decision Date | 2004-03-11 |
Summary: | summary |