The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Stand, Infusion.
Device ID | K946201 |
510k Number | K946201 |
Device Name: | STAND, INFUSION |
Classification | Stand, Infusion |
Applicant | MEDICAL SPECIALTIES, INC. 58 NORFOLK AVE. South Easton, MA 02375 -0600 |
Contact | John Whisnant |
Correspondent | John Whisnant MEDICAL SPECIALTIES, INC. 58 NORFOLK AVE. South Easton, MA 02375 -0600 |
Product Code | FOX |
CFR Regulation Number | 880.6990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-21 |
Decision Date | 1995-04-18 |