The following data is part of a premarket notification filed by Emily Iker M.d., A.p.c. with the FDA for Dm Sleeve.
Device ID | K021102 |
510k Number | K021102 |
Device Name: | DM SLEEVE |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | EMILY IKER M.D., A.P.C. 555 THIRTEENTH ST. Washington, DC |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan EMILY IKER M.D., A.P.C. 555 THIRTEENTH ST. Washington, DC |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-04 |
Decision Date | 2002-05-08 |
Summary: | summary |