The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Percutaneous Endoscopic Gastrostomy Tray.
Device ID | K874936 |
510k Number | K874936 |
Device Name: | MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Donna Plante |
Correspondent | Donna Plante MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-04 |
Decision Date | 1988-04-14 |