The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Biospal 2400s.
Device ID | K834579 |
510k Number | K834579 |
Device Name: | BIOSPAL 2400S |
Classification | Container, Specimen Mailer And Storage, Sterile |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDT |
CFR Regulation Number | 864.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-29 |
Decision Date | 1984-02-04 |