The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Sterile Irrigating Syringes, Kits,tray.
| Device ID | K813027 |
| 510k Number | K813027 |
| Device Name: | STERILE IRRIGATING SYRINGES, KITS,TRAY |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | WELCON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15075040 | K813027 | 000 |
| B15075030 | K813027 | 000 |
| B15073040 | K813027 | 000 |
| B15073030 | K813027 | 000 |
| B15072040 | K813027 | 000 |
| B15072030 | K813027 | 000 |
| B150372340 | K813027 | 000 |