Submission Details
| 510(k) Number | K880855 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1988 |
| Decision Date | April 01, 1988 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
Apr 1988
Decision
31d
Days
Class 1
Risk
About This 510(k) Submission
K880855 is an FDA 510(k) clearance for the PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG, a Magnet, Permanent (Class I — General Controls, product code HPN), submitted by Richard James, Inc. (Lynnfield, US). The FDA issued a Cleared decision on April 1, 1988, 31 days after receiving the submission on March 1, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4445.
Device Classification
| Product Code | HPN — Magnet, Permanent |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4445 |
Manufacturer
Similar Devices — HPN Magnet, Permanent
K905237 · King Tool, Inc.
· Feb 1991
K896473 · Emory University School of Medicine
· Feb 1990
K860960 · Ameritek, Inc.
· Mar 1986
K831702 · Miami Eye Technology, Inc.
· Jun 1983