The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Patient Safe Syringe.
Device ID | K072654 |
510k Number | K072654 |
Device Name: | PATIENT SAFE SYRINGE |
Classification | Syringe, Piston |
Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
Contact | Rhonda Wells |
Correspondent | Rhonda Wells RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-20 |
Decision Date | 2007-12-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613703560025 | K072654 | 000 |
00613703530028 | K072654 | 000 |
00613703520029 | K072654 | 000 |
00613703510020 | K072654 | 000 |
00613703505026 | K072654 | 000 |
00613703503022 | K072654 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATIENT SAFE SYRINGE 85283764 4136822 Live/Registered |
Retractable Technologies, Inc. 2011-04-01 |
PATIENT SAFE SYRINGE 77170321 not registered Dead/Abandoned |
Retractable Technologies, Inc. 2007-05-01 |