The following data is part of a premarket notification filed by Pall Medical with the FDA for Laparoshield Conditioned Insufflation Set.
| Device ID | K030469 |
| 510k Number | K030469 |
| Device Name: | LAPAROSHIELD CONDITIONED INSUFFLATION SET |
| Classification | Insufflator, Laparoscopic |
| Applicant | PALL MEDICAL 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan PALL MEDICAL 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-05-09 |
| Summary: | summary |