The following data is part of a premarket notification filed by Medical Hospital Equipment with the FDA for R.r. Pronto Siringa.
Device ID | K852503 |
510k Number | K852503 |
Device Name: | R.R. PRONTO SIRINGA |
Classification | Syringe, Piston |
Applicant | MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
Contact | Vincent A Maruca |
Correspondent | Vincent A Maruca MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-12 |
Decision Date | 1985-11-13 |