SURGICAL DRAPES, OPHTHALMIN

Drape, Patient, Ophthalmic

CHARLES ATKINS & CO.

The following data is part of a premarket notification filed by Charles Atkins & Co. with the FDA for Surgical Drapes, Ophthalmin.

Pre-market Notification Details

• Device ID: K854613
• 510k Number: K854613
• Device Name: SURGICAL DRAPES, OPHTHALMIN
• Classification: Drape, Patient, Ophthalmic
• Applicant: CHARLES ATKINS & CO. 5801 PEACHTREE DUNWOODY RD. Atlanta, GA 30342
• Contact: Charles R Atkins
• Correspondent: Charles R Atkins; CHARLES ATKINS & CO. 5801 PEACHTREE DUNWOODY RD. Atlanta, GA 30342
• Product Code: HMT
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-18
• Decision Date: 1986-02-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10851736007002	K854613	000
10851736007316	K854613	000
10851736007323	K854613	000
10851736007330	K854613	000
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10851736007415	K854613	000
10851736007514	K854613	000
10851736007521	K854613	000
10851736007705	K854613	000
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10852171007091	K854613	000
10852171007107	K854613	000
10852171007114	K854613	000
10852171007121	K854613	000
10852171007251	K854613	000
10852171007268	K854613	000
10852171007275	K854613	000
10852171007282	K854613	000
10852171007299	K854613	000
10852171007305	K854613	000
10852171007312	K854613	000
10852171007329	K854613	000
10852171007350	K854613	000
10852171007008	K854613	000