The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Mask, Anesth. Inflatable & Pediatric Scented, Disp.
Device ID | K880682 |
510k Number | K880682 |
Device Name: | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP |
Classification | Mask, Gas, Anesthetic |
Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
Contact | Linda L Nordlund |
Correspondent | Linda L Nordlund KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
Product Code | BSJ |
CFR Regulation Number | 868.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-19 |
Decision Date | 1988-03-21 |