The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Mcdonald Folding Forceps.
Device ID | K885230 |
510k Number | K885230 |
Device Name: | MCDONALD FOLDING FORCEPS |
Classification | Forceps, Ophthalmic |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | Rebecca G Walker |
Correspondent | Rebecca 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 | 1988-12-20 |
Decision Date | 1989-05-17 |