The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-pc.
Device ID | K880608 |
510k Number | K880608 |
Device Name: | MSI-PC |
Classification | Control, Platelet |
Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
Contact | Ron Devita |
Correspondent | Ron Devita MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
Product Code | GJP |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-12 |
Decision Date | 1988-03-21 |