The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Cuffcheck.
Device ID | K881178 |
510k Number | K881178 |
Device Name: | CUFFCHECK |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Contact | Jean Wallace |
Correspondent | Jean Wallace DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-18 |
Decision Date | 1988-04-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUFFCHECK 73453638 1307875 Dead/Cancelled |
Medical Electronics Corporation 1983-11-21 |