The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Aspen Surgical Systems Insufflation Tubing Set With Filter.
| Device ID | K943954 |
| 510k Number | K943954 |
| Device Name: | ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER |
| Classification | Insufflator, Laparoscopic |
| Applicant | CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Contact | Ira D Duesler |
| Correspondent | Ira D Duesler CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1994-11-15 |