The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Suction Tube Tip Fits Over Bussie Frazier Tube.
Device ID | K872906 |
510k Number | K872906 |
Device Name: | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
Contact | Ed Greenspan |
Correspondent | Ed Greenspan AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-24 |
Decision Date | 1987-08-11 |