The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for High Pressure Connecting Sets, Modification.
| Device ID | K914987 |
| 510k Number | K914987 |
| Device Name: | HIGH PRESSURE CONNECTING SETS, MODIFICATION |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-24 |
| Decision Date | 1992-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787123008015 | K914987 | 000 |