The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demequicktm (rapid Absorbable) Synthetic Surgical Suture.
Device ID | K123940 |
510k Number | K123940 |
Device Name: | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DEMETECH CORP. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
Contact | John O'brien |
Correspondent | John O'brien DEMETECH CORP. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-20 |
Decision Date | 2014-05-30 |
Summary: | summary |