The following data is part of a premarket notification filed by Normatec, Inc. with the FDA for Normatec Pcd.
Device ID | K013436 |
510k Number | K013436 |
Device Name: | NORMATEC PCD |
Classification | Sleeve, Limb, Compressible |
Applicant | NORMATEC, INC. 555 THIREENTH ST. Washington, DC |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan NORMATEC, INC. 555 THIREENTH ST. Washington, DC |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-16 |
Decision Date | 2001-12-21 |
Summary: | summary |