AM-100 I/A Ampac

FDA 510(k) K860770 · Dravon Medical, Inc.

Substantially Equivalent

510(k) numberK860770

Submission

Device name
AM-100 I/A Ampac
Applicant
Dravon Medical, Inc.
Clackamas, OR, US
Received
March 3, 1986
Decision date
April 21, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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Questions and answers

When was AM-100 I/A Ampac cleared by the FDA?

AM-100 I/A Ampac (K860770) received a 510(k) decision of Substantially Equivalent on April 21, 1986, 49 days after the submission was received.

What is the product code of K860770?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.