SPECTRUM DESIGNS PROJECTION MALAR IMPLANT

Implant, Malar

SPECTRUM DESIGNS, INC.

The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Projection Malar Implant.

Pre-market Notification Details

• Device ID: K980141
• 510k Number: K980141
• Device Name: SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
• Classification: Implant, Malar
• Applicant: SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta, CA 93117
• Contact: Jim Dishman
• Correspondent: Jim Dishman; SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta, CA 93117
• Product Code: LZK
• CFR Regulation Number: 878.3550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-15
• Decision Date: 1998-03-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M724130334S1	K980141	000
M724130324S1	K980141	000
M724130314S1	K980141	000
M7249000111	K980141	000