The following data is part of a premarket notification filed by Microvasive with the FDA for Low Profile Gastrostomy.
Device ID | K872771 |
510k Number | K872771 |
Device Name: | LOW PROFILE GASTROSTOMY |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Contact | Samuel D Wade |
Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-14 |
Decision Date | 1987-10-09 |