Question 1

Who is the manufacturer of PRO-PAK FOR OMS DIPLOMATE?

Accepted Answer

M. Imonti and Associates Inc., filed the 510(k) submission for PRO-PAK FOR OMS DIPLOMATE (K950800).

Question 2

What is the FDA product code for PRO-PAK FOR OMS DIPLOMATE?

Accepted Answer

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

Question 3

When was PRO-PAK FOR OMS DIPLOMATE cleared by the FDA?

Accepted Answer

May 22, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for PRO-PAK FOR OMS DIPLOMATE?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like PRO-PAK FOR OMS DIPLOMATE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K950800
Device Name	PRO-PAK FOR OMS DIPLOMATE
Applicant	M. Imonti and Associates Inc.,
Product Code	HQC · Ophthalmic
Decision Date	May 22, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

PRO-PAK FOR OMS DIPLOMATE

Device Facts

Regulatory Classification

Identification