Question 1

Who is the manufacturer of SURE DROP?

Accepted Answer

Sheldon Eyedrop Support, Inc. filed the 510(k) submission for SURE DROP (K870905).

Question 2

When was SURE DROP cleared by the FDA?

Accepted Answer

Apr 24, 1987 (decision: SESE).

Question 3

What is the regulatory pathway for SURE DROP?

Accepted Answer

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

Question 4

Who can help prepare an FDA 510(k) submission like SURE DROP?

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	K870905
Device Name	SURE DROP
Applicant	Sheldon Eyedrop Support, Inc.
Decision Date	Apr 24, 1987
Decision	SESE
Submission Type	Traditional

SURE DROP

Device Facts