LOOK RETROBULBAR NEEDLES— 510(k) K870902

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K870902 for LOOK RETROBULBAR NEEDLES, Substantially Equivalent on 1987-03-20. Applicant: Look, Inc.. Device class: 1.

Clearance details

Applicant
Look, Inc.
Product code
Code HMX
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boston, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HMX

product code HMX
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.