The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Non-absorbable Surgical Sutures.
Device ID | K930517 |
510k Number | K930517 |
Device Name: | NON-ABSORBABLE SURGICAL SUTURES |
Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | David Krapf |
Correspondent | David Krapf ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Product Code | GAR |
CFR Regulation Number | 878.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1993-12-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10380657122018 | K930517 | 000 |
00380652080019 | K930517 | 000 |
10380652021019 | K930517 | 000 |
10380652020012 | K930517 | 000 |
10380652017012 | K930517 | 000 |
10380652012017 | K930517 | 000 |
10380651985015 | K930517 | 000 |
10380651982014 | K930517 | 000 |
10380651981017 | K930517 | 000 |
10380651980010 | K930517 | 000 |
10380651942018 | K930517 | 000 |
10380651941011 | K930517 | 000 |
10380651931012 | K930517 | 000 |
10380651930015 | K930517 | 000 |
10380651922010 | K930517 | 000 |
10380651921013 | K930517 | 000 |
10380652081013 | K930517 | 000 |
10380652115015 | K930517 | 000 |
00380657121014 | K930517 | 000 |
10380657117014 | K930517 | 000 |
10380657104014 | K930517 | 000 |
10380657100016 | K930517 | 000 |
10380657021014 | K930517 | 000 |
10380657020017 | K930517 | 000 |
10380656980015 | K930517 | 000 |
10380656931017 | K930517 | 000 |
10380656930010 | K930517 | 000 |
10380656921018 | K930517 | 000 |
10380656920011 | K930517 | 000 |
10380656919015 | K930517 | 000 |
10380652221013 | K930517 | 000 |
10380652186015 | K930517 | 000 |
10380652155011 | K930517 | 000 |
10380651920016 | K930517 | 000 |