The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Inman Poole Tip Suction Probe W/tubing Kit.
Device ID | K933170 |
510k Number | K933170 |
Device Name: | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
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 | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-29 |
Decision Date | 1993-09-16 |