The following data is part of a premarket notification filed by Arbor Technologies, Inc. with the FDA for Pressure Tubing And Accessories.
Device ID | K922777 |
510k Number | K922777 |
Device Name: | PRESSURE TUBING AND ACCESSORIES |
Classification | Insufflator, Laparoscopic |
Applicant | ARBOR TECHNOLOGIES, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
Contact | Dawn I Moore |
Correspondent | Dawn I Moore ARBOR TECHNOLOGIES, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-09 |
Decision Date | 1994-03-22 |