The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Non-rebreathing Tee Piece (nrtp).
Device ID | K883988 |
510k Number | K883988 |
Device Name: | NON-REBREATHING TEE PIECE (NRTP) |
Classification | Valve, Non-rebreathing |
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 | CBP |
CFR Regulation Number | 868.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-20 |
Decision Date | 1988-10-07 |