The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Snowden-pencer Computerized High Flow Insufflator.
| Device ID | K962683 |
| 510k Number | K962683 |
| Device Name: | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | DEKNATEL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane E Minear, Rac |
| Correspondent | Diane E Minear, Rac DEKNATEL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-10 |
| Decision Date | 1997-01-10 |
| Summary: | summary |