The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for (msi) Path-saver.
Device ID | K872140 |
510k Number | K872140 |
Device Name: | (MSI) PATH-SAVER |
Classification | Formalin, Neutral Buffered |
Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
Contact | Ronald Devita |
Correspondent | Ronald Devita MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
Product Code | IFP |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-02 |
Decision Date | 1987-06-15 |