The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Quick-tap Paracentesis Tray, Kit & Needle.
| Device ID | K030721 |
| 510k Number | K030721 |
| Device Name: | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE |
| Classification | General Surgery Tray |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | Cindy Ellis |
| Correspondent | Cindy Ellis BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-07 |
| Decision Date | 2003-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651927959 | K030721 | 000 |
| 10350770926770 | K030721 | 000 |
| 10350770927913 | K030721 | 000 |
| 10350770927920 | K030721 | 000 |
| 10350770927944 | K030721 | 000 |
| 30680651926778 | K030721 | 000 |
| 30680651927911 | K030721 | 000 |
| 30680651927928 | K030721 | 000 |
| 30680651927942 | K030721 | 000 |
| 10350770927951 | K030721 | 000 |