The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz/mazzacco Lens Forcep.
Device ID | K860915 |
510k Number | K860915 |
Device Name: | STORZ/MAZZACCO LENS FORCEP |
Classification | Forceps, Ophthalmic |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Rick Mccarley |
Correspondent | Rick Mccarley STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-11 |
Decision Date | 1986-04-15 |