The following data is part of a premarket notification filed by Cryogenic Assoc. with the FDA for Liberator/stroller Ii System.
Device ID | K800742 |
510k Number | K800742 |
Device Name: | LIBERATOR/STROLLER II SYSTEM |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | CRYOGENIC ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-03 |
Decision Date | 1980-05-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M766132595990 | K800742 | 000 |
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