The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Aquacade.
Device ID | K811524 |
510k Number | K811524 |
Device Name: | AQUACADE |
Classification | Warmer, Irrigation Solution |
Applicant | RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHC |
CFR Regulation Number | 890.5950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-29 |
Decision Date | 1981-07-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AQUACADE 73018786 1007331 Dead/Expired |
RESPIRATORY CARE, INC. 1974-04-15 |
AQUACADE 73004083 1022641 Dead/Expired |
RAMCO MANUFACTURING, INC. 1973-10-19 |
AQUACADE 72387348 0937744 Dead/Expired |
AVON PRODUCTS, INC. 1971-03-25 |