Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K222348 |
Device Name |
JR MEDIC |
Applicant |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Lot 8 &10, Jalan Zurah 3 & Lot 1&3, |
Jalan Zurah 3A/1, Pusat Perindustrian 2, |
Hulu Selangor,
MY
44200
|
|
Applicant Contact |
Ganesan Subramaniam |
Correspondent |
Liberty Management Group Ltd. |
75 Executive Dr. STE 114 |
Aurora,
IL
60504
|
|
Correspondent Contact |
Manoj Zacharias |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/03/2022 |
Decision Date | 10/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|