The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Surgiquest Anchorport Sil Kit.
Device ID | K100180 |
510k Number | K100180 |
Device Name: | SURGIQUEST ANCHORPORT SIL KIT |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
Contact | Kourosh Azarbarzin |
Correspondent | Kourosh Azarbarzin SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-21 |
Decision Date | 2010-05-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20851885004430 | K100180 | 000 |
20851885004416 | K100180 | 000 |
20851885004393 | K100180 | 000 |
20845854046439 | K100180 | 000 |
20845854046415 | K100180 | 000 |