The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Disposable, Filtered Insufflation Tubing, 92-900.
Device ID | K921963 |
510k Number | K921963 |
Device Name: | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 |
Classification | Insufflator, Laparoscopic |
Applicant | SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
Contact | David Lee |
Correspondent | David Lee SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-27 |
Decision Date | 1992-09-11 |