The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-slip Flat Suction Drain.
Device ID | K926408 |
510k Number | K926408 |
Device Name: | SIL-SLIP FLAT SUCTION DRAIN |
Classification | Catheter, Irrigation |
Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
Contact | V Concepcion |
Correspondent | V Concepcion SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
Product Code | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1994-02-02 |