The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Rate-mate Nitroglycerin I.v. Administration Set.
Device ID | K873729 |
510k Number | K873729 |
Device Name: | RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Contact | Raymond E Ursick |
Correspondent | Raymond E Ursick CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1987-12-29 |