The following data is part of a premarket notification filed by Optical Center with the FDA for Retractive Incision Micrometer (rim) Guage.
Device ID | K882402 |
510k Number | K882402 |
Device Name: | RETRACTIVE INCISION MICROMETER (RIM) GUAGE |
Classification | Knife, Ophthalmic |
Applicant | OPTICAL CENTER 1800 LOCKWOOD ST. Oxnard, CA 93030 |
Contact | John Watkins |
Correspondent | John Watkins OPTICAL CENTER 1800 LOCKWOOD ST. Oxnard, CA 93030 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-10 |
Decision Date | 1988-08-22 |