Phacotron Day Pak

FDA 510(k) K870671 · United Surgical Corp.

Substantially Equivalent

510(k) numberK870671

Submission

Device name
Phacotron Day Pak
Applicant
United Surgical Corp.
Irvine, CA, US
Received
February 19, 1987
Decision date
April 6, 1987
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 Phacotron Day Pak cleared by the FDA?

Phacotron Day Pak (K870671) received a 510(k) decision of Substantially Equivalent on April 6, 1987, 46 days after the submission was received.

What is the product code of K870671?

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