FLO-RESTER

Clamp, Vascular

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Flo-rester.

Pre-market Notification Details

• Device ID: K883696
• 510k Number: K883696
• Device Name: FLO-RESTER
• Classification: Clamp, Vascular
• Applicant: BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113
• Contact: Sherry A Krattley
• Correspondent: Sherry A Krattley; BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-08-30
• Decision Date: 1988-11-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412532153	K883696	000
50085412532009	K883696	000
50085412531996	K883696	000
50085412531989	K883696	000
50085412531972	K883696	000
50085412531965	K883696	000
50085412531958	K883696	000
50085412531941	K883696	000
50085412531934	K883696	000
50085412531927	K883696	000
50085412531910	K883696	000
50085412532016	K883696	000
50085412532047	K883696	000
50085412532146	K883696	000
50085412532139	K883696	000
50085412532122	K883696	000
50085412532115	K883696	000
50085412532108	K883696	000
50085412532092	K883696	000
50085412532085	K883696	000
50085412532078	K883696	000
50085412532061	K883696	000
50085412532054	K883696	000
50085412531903	K883696	000