The following data is part of a premarket notification filed by Julius Zorn, Inc. with the FDA for Medical Support Stockings 2001/2002.
Device ID | K943734 |
510k Number | K943734 |
Device Name: | MEDICAL SUPPORT STOCKINGS 2001/2002 |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | JULIUS ZORN, INC. 80 CHART RD. P.O. BOX 1088 Cuyahoga Falls, OH 44223 -0088 |
Contact | Chad Thompson |
Correspondent | Chad Thompson JULIUS ZORN, INC. 80 CHART RD. P.O. BOX 1088 Cuyahoga Falls, OH 44223 -0088 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-02 |
Decision Date | 1994-10-19 |