The following data is part of a premarket notification filed by Gi Supply with the FDA for Runyon Large Volume Paracentesis Kit.
| Device ID | K970187 |
| 510k Number | K970187 |
| Device Name: | RUNYON LARGE VOLUME PARACENTESIS KIT |
| Classification | General Surgery Tray |
| Applicant | GI SUPPLY P.O. BOX 289 Willington, CT 06279 |
| Contact | Robert G Whalen |
| Correspondent | Robert G Whalen GI SUPPLY P.O. BOX 289 Willington, CT 06279 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10893029002004 | K970187 | 000 |
| 00893029002175 | K970187 | 000 |
| 00893029002151 | K970187 | 000 |
| 10893029002233 | K970187 | 000 |
| 10893029002165 | K970187 | 000 |