The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Kab System.
Device ID | K951093 |
510k Number | K951093 |
Device Name: | KAB SYSTEM |
Classification | Absorber, Carbon-dioxide |
Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
Contact | Michael A Leagre |
Correspondent | Michael A Leagre KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
Product Code | BSF |
CFR Regulation Number | 868.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-09 |
Decision Date | 1995-03-24 |