COTTON 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 Cotton Neurological Sponge.

Pre-market Notification Details

• Device ID: K854713
• 510k Number: K854713
• Device Name: COTTON NEUROLOGICAL SPONGE
• Classification: Neurosurgical Paddie
• Applicant: AMERICAN SILK SUTURES, INC. P.O. BOX 370 Ledyard, CT 06339
• Contact: Miller
• Correspondent: Miller; AMERICAN SILK SUTURES, INC. P.O. BOX 370 Ledyard, CT 06339
• Product Code: HBA
• CFR Regulation Number: 882.4700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-22
• Decision Date: 1986-03-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00749915002593	K854713	000
20749915000128	K854713	000
20749915000135	K854713	000
20749915000142	K854713	000
20749915000159	K854713	000
20749915000166	K854713	000
20749915000173	K854713	000
20749915000180	K854713	000
20749915000203	K854713	000
20749915000210	K854713	000
20749915000234	K854713	000
20749915000241	K854713	000
20749915000111	K854713	000
20749915000104	K854713	000
00749915002609	K854713	000
00749915002616	K854713	000
00749915002623	K854713	000
00749915002630	K854713	000
00749915002647	K854713	000
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20749915000036	K854713	000
20749915000050	K854713	000
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20749915000081	K854713	000
20749915000258	K854713	000
20749915000265	K854713	000
20749915000272	K854713	000
20749915000425	K854713	000
20749915000432	K854713	000
20749915000449	K854713	000
20749915000456	K854713	000
20749915000463	K854713	000
20749915000470	K854713	000
20749915000487	K854713	000
20749915000494	K854713	000
20749915000500	K854713	000
30749915000224	K854713	000
30749915000316	K854713	000
20749915000418	K854713	000
20749915000401	K854713	000
20749915000289	K854713	000
20749915000296	K854713	000
20749915000302	K854713	000
20749915000326	K854713	000
20749915000333	K854713	000
20749915000340	K854713	000
20749915000357	K854713	000
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20749915000371	K854713	000
20749915000388	K854713	000
20749915000395	K854713	000
40749915000207	K854713	000