The following data is part of a premarket notification filed by Med-plastics Intl., Inc. with the FDA for Med-plastics Intl., Inc. Breathing Filter.
Device ID | K930760 |
510k Number | K930760 |
Device Name: | MED-PLASTICS INTL., INC. BREATHING FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
Contact | Michael Campbell |
Correspondent | Michael Campbell MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-12 |
Decision Date | 1993-03-11 |