The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-slip (coated/regular(non-coated)thoracic Drain.
Device ID | K926496 |
510k Number | K926496 |
Device Name: | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN |
Classification | Catheter, Irrigation |
Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
Contact | Karen K Sylvia |
Correspondent | Karen K Sylvia 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 | 1992-12-29 |
Decision Date | 1995-05-24 |