The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Manual Ophthalmic Surgical Instruments.
Device ID | K873099 |
510k Number | K873099 |
Device Name: | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS |
Classification | Scissors, Ophthalmic |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Contact | Rebecca G Walker |
Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Product Code | HNF |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-07 |
Decision Date | 1987-09-04 |