The following data is part of a premarket notification filed by Spiess Design, Inc. with the FDA for Co2 Insufflator High Flow Electronic Insufflator.
Device ID | K920114 |
510k Number | K920114 |
Device Name: | CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR |
Classification | Insufflator, Laparoscopic |
Applicant | SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
Contact | Dieter Keppel |
Correspondent | Dieter Keppel SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-10 |
Decision Date | 1992-04-06 |