The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Plastic Blunt Cannula.
Device ID | K952976 |
510k Number | K952976 |
Device Name: | PLASTIC BLUNT CANNULA |
Classification | Set, Administration, Intravascular |
Applicant | MARQUETTE MEDICAL, INC. 1114 BENFIELD BLVD., SUITE K Millersville, MD 21108 |
Contact | Earl D Marquette, Jr. |
Correspondent | Earl D Marquette, Jr. MARQUETTE MEDICAL, INC. 1114 BENFIELD BLVD., SUITE K Millersville, MD 21108 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-27 |
Decision Date | 1995-09-15 |