SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)

Catheter, Conduction, Anesthetic

EPIMED INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models).

Pre-market Notification Details

• Device ID: K133316
• 510k Number: K133316
• Device Name: SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
• Classification: Catheter, Conduction, Anesthetic
• Applicant: EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095
• Contact: Preston H Frasier
• Correspondent: Preston H Frasier; EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095
• Product Code: BSO
• CFR Regulation Number: 868.5120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-28
• Decision Date: 2014-05-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10818788021370	K133316	000
10818788021363	K133316	000
10818788021356	K133316	000
10818788021349	K133316	000
10818788021332	K133316	000
10818788021325	K133316	000
10818788021318	K133316	000
10818788021301	K133316	000