The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-med T-tube Drain.
Device ID | K903989 |
510k Number | K903989 |
Device Name: | SIL-MED T-TUBE DRAIN |
Classification | Drain, Cervical |
Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
Contact | William S Mccallum |
Correspondent | William S Mccallum SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
Product Code | HFL |
CFR Regulation Number | 884.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-29 |
Decision Date | 1991-01-31 |