The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Insufflator Tubing Kit W/filter.
Device ID | K933094 |
510k Number | K933094 |
Device Name: | INSUFFLATOR TUBING KIT W/FILTER |
Classification | Insufflator, Laparoscopic |
Applicant | INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Contact | Pam Liberto |
Correspondent | Pam Liberto INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-24 |
Decision Date | 1994-04-18 |