The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Sensing Syringe 65000.
Device ID | K853586 |
510k Number | K853586 |
Device Name: | PRESSURE SENSING SYRINGE 65000 |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Ronald A Williams |
Correspondent | Ronald A Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-26 |
Decision Date | 1985-11-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994918530 | K853586 | 000 |
20613994918493 | K853586 | 000 |