The following data is part of a premarket notification filed by Nusurg, Inc. with the FDA for Talc Dispenser Syringe.
Device ID | K930610 |
510k Number | K930610 |
Device Name: | TALC DISPENSER SYRINGE |
Classification | Syringe, Irrigating (non Dental) |
Applicant | NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
Contact | Dennis R Lackey |
Correspondent | Dennis R Lackey NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
Product Code | KYZ |
CFR Regulation Number | 880.6960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-05 |
Decision Date | 1993-11-04 |