The following data is part of a premarket notification filed by Allegiance Healthcare Corporation with the FDA for Small Volume Nebulizer.
Device ID | K023602 |
510k Number | K023602 |
Device Name: | SMALL VOLUME NEBULIZER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park, IL 60085 |
Contact | Sharon Nichols |
Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park, IL 60085 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-28 |
Decision Date | 2003-05-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30889483587168 | K023602 | 000 |
30889483599093 | K023602 | 000 |
30889483571976 | K023602 | 000 |
30889483571044 | K023602 | 000 |
30889483571051 | K023602 | 000 |
30889483571068 | K023602 | 000 |
30889483571075 | K023602 | 000 |
30889483571082 | K023602 | 000 |
30889483571099 | K023602 | 000 |
30889483571105 | K023602 | 000 |
30889483571150 | K023602 | 000 |
30889483571174 | K023602 | 000 |
30889483571198 | K023602 | 000 |
30889483571938 | K023602 | 000 |
30889483571235 | K023602 | 000 |
30889483583351 | K023602 | 000 |