The following data is part of a premarket notification filed by Valumed with the FDA for Snap Kover, Model 01-2020; Snap Kaps, Model 03-kp09.
| Device ID | K023540 | 
| 510k Number | K023540 | 
| Device Name: | SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 | 
| Classification | Cover, Barrier, Protective | 
| Applicant | VALUMED 1439 LIVE OAK ST. SUITE A Niceville, FL 32578 | 
| Contact | Thomas E Cottone | 
| Correspondent | Thomas E Cottone VALUMED 1439 LIVE OAK ST. SUITE A Niceville, FL 32578 | 
| Product Code | MMP | 
| CFR Regulation Number | 878.4370 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2002-10-22 | 
| Decision Date | 2003-02-04 | 
| Summary: | summary |