The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Folding Forceps.
Device ID | K895434 |
510k Number | K895434 |
Device Name: | ALCON FOLDING FORCEPS |
Classification | Forceps, Ophthalmic |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | G Walker |
Correspondent | G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-08 |
Decision Date | 1989-12-04 |