The following data is part of a premarket notification filed by Cheung Laboratories, Inc. with the FDA for Diathermy Device-microfocus.
Device ID | K941567 |
510k Number | K941567 |
Device Name: | DIATHERMY DEVICE-MICROFOCUS |
Classification | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat |
Applicant | CHEUNG LABORATORIES, INC. 10220 - I OLD COLUMBIA RD. Columbia, MD 21046 -1890 |
Contact | Dennis Smith |
Correspondent | Dennis Smith CHEUNG LABORATORIES, INC. 10220 - I OLD COLUMBIA RD. Columbia, MD 21046 -1890 |
Product Code | IOA |
CFR Regulation Number | 890.5275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-01 |
Decision Date | 1996-04-22 |