The following data is part of a premarket notification filed by Aragon Surgical Inc. with the FDA for Aragon Surgical Lapcap.
| Device ID | K070651 |
| 510k Number | K070651 |
| Device Name: | ARAGON SURGICAL LAPCAP |
| Classification | Insufflator, Laparoscopic |
| Applicant | ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B Palo Alto, CA 94303 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B Palo Alto, CA 94303 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-09 |
| Decision Date | 2007-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060484670002 | K070651 | 000 |