RAYON NEUROLOGICAL SPONGE

Neurosurgical Paddie

AMERICAN SILK SUTURES, INC.

The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Rayon Neurological Sponge.

Pre-market Notification Details

• Device ID: K902921
• 510k Number: K902921
• Device Name: RAYON NEUROLOGICAL SPONGE
• Classification: Neurosurgical Paddie
• Applicant: AMERICAN SILK SUTURES, INC. 82 SANDERSON AVE. Lynn, MA 01902
• Contact: Win Hirsch
• Correspondent: Win Hirsch; AMERICAN SILK SUTURES, INC. 82 SANDERSON AVE. Lynn, MA 01902
• Product Code: HBA
• CFR Regulation Number: 882.4700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-03
• Decision Date: 1990-09-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00749915002937	K902921	000
20749915000883	K902921	000
20749915000920	K902921	000
20749915000944	K902921	000
20749915000951	K902921	000
20749915000968	K902921	000
20749915000975	K902921	000
20749915000982	K902921	000
20749915000999	K902921	000
20749915001002	K902921	000
20749915001019	K902921	000
20749915001026	K902921	000
20749915001033	K902921	000
20749915001040	K902921	000
20749915001057	K902921	000
20749915001064	K902921	000
20749915001071	K902921	000
20749915000869	K902921	000
20749915000845	K902921	000
00749915002944	K902921	000
10749915002842	K902921	000
10749915002866	K902921	000
10749915002880	K902921	000
10749915002903	K902921	000
20749915002733	K902921	000
10749915002767	K902921	000
10749915002781	K902921	000
10749915002811	K902921	000
10749915002828	K902921	000
10749915002668	K902921	000
20749915000777	K902921	000
20749915000784	K902921	000
20749915000791	K902921	000
20749915000807	K902921	000
20749915000821	K902921	000
20749915001088	K902921	000
20749915001095	K902921	000
20749915001477	K902921	000
20749915001491	K902921	000
20749915001514	K902921	000
20749915001521	K902921	000
20749915001538	K902921	000
20749915001545	K902921	000
20749915001552	K902921	000
20749915001569	K902921	000
20749915001576	K902921	000
20749915001583	K902921	000
20749915001590	K902921	000
20749915001606	K902921	000
20749915001613	K902921	000
20749915001620	K902921	000
20749915001637	K902921	000
20749915001644	K902921	000
20749915001453	K902921	000
20749915001439	K902921	000
20749915001101	K902921	000
20749915001132	K902921	000
20749915001163	K902921	000
20749915001194	K902921	000
20749915001217	K902921	000
20749915001231	K902921	000
20749915001255	K902921	000
20749915001279	K902921	000
20749915001309	K902921	000
20749915001316	K902921	000
20749915001330	K902921	000
20749915001347	K902921	000
20749915001354	K902921	000
20749915001361	K902921	000
20749915001385	K902921	000
20749915001408	K902921	000
30749915000903	K902921	000