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 |