The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Polypropilene Surgical Sutures.
Device ID | K043330 |
510k Number | K043330 |
Device Name: | POLYPROPILENE SURGICAL SUTURES |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | DEMETECH CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward DEMETECH CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-02 |
Decision Date | 2005-05-16 |
Summary: | summary |