The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Burlew Infant Hood.
Device ID | K962182 |
510k Number | K962182 |
Device Name: | BURLEW INFANT HOOD |
Classification | Hood, Oxygen, Infant |
Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | FOG |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-06 |
Decision Date | 1996-07-15 |
Summary: | summary |