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 |