PATIENT RESTRAINT

Restraint, Protective

E.M. ADAMS CO., INC.

The following data is part of a premarket notification filed by E.m. Adams Co., Inc. with the FDA for Patient Restraint.

Pre-market Notification Details

• Device ID: K971948
• 510k Number: K971948
• Device Name: PATIENT RESTRAINT
• Classification: Restraint, Protective
• Applicant: E.M. ADAMS CO., INC. 7496 COMMERCIAL CIRCLE Fort Pierce, FL 34951
• Contact: Richard K Donahue
• Correspondent: Richard K Donahue; E.M. ADAMS CO., INC. 7496 COMMERCIAL CIRCLE Fort Pierce, FL 34951
• Product Code: FMQ
• CFR Regulation Number: 880.6760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-28
• Decision Date: 1997-08-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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