The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for 10.0mm Suction/irrigation Probe & Tubing Kit.
Device ID | K932762 |
510k Number | K932762 |
Device Name: | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT |
Classification | Endoscope, Battery-powered And Accessories |
Applicant | INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Contact | John Mayall |
Correspondent | John Mayall INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Product Code | GCS |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-08 |
Decision Date | 1993-08-31 |