The following data is part of a premarket notification filed by Zutron Medical Llc with the FDA for Zutron Medical Endoscope Leak Tester Model Zutr-10003.
| Device ID | K093718 |
| 510k Number | K093718 |
| Device Name: | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 |
| Classification | Bulb, Inflation, For Endoscope |
| Applicant | ZUTRON MEDICAL LLC 9816 PFLUMM RD Lenexa, KS 66215 |
| Contact | Jordan Hartong |
| Correspondent | Jordan Hartong ZUTRON MEDICAL LLC 9816 PFLUMM RD Lenexa, KS 66215 |
| Product Code | FCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-02 |
| Decision Date | 2010-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333244515 | K093718 | 000 |
| 04961333244508 | K093718 | 000 |
| 04961333244492 | K093718 | 000 |
| 04961333244485 | K093718 | 000 |
| 04961333244478 | K093718 | 000 |
| 04961333244461 | K093718 | 000 |