The following data is part of a premarket notification filed by Clinitex Medical Corp. with the FDA for Clinitex Cast Padding.
| Device ID | K973420 |
| 510k Number | K973420 |
| Device Name: | CLINITEX CAST PADDING |
| Classification | Component, Cast |
| Applicant | CLINITEX MEDICAL CORP. 9801 KINCEY AVE., SUITE 100 Huntersville, NC 28078 |
| Contact | Howell H Michael |
| Correspondent | Howell H Michael CLINITEX MEDICAL CORP. 9801 KINCEY AVE., SUITE 100 Huntersville, NC 28078 |
| Product Code | LGF |
| CFR Regulation Number | 888.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-12-09 |