SPECTRUM DISIGNS PECTORAL IMPLANT

Implant, Muscle, Pectoralis

SPECTRUM DESIGNS, INC.

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

Pre-market Notification Details

• Device ID: K944163
• 510k Number: K944163
• Device Name: SPECTRUM DISIGNS PECTORAL IMPLANT
• Classification: Implant, Muscle, Pectoralis
• 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: MIC
• CFR Regulation Number: 874.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-26
• Decision Date: 1994-11-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M724BNPI3T1R1	K944163	000
M724BNPI2S1R1	K944163	000
M724BNPI2S1L1	K944163	000
M724ACPI4S3R1	K944163	000
M724ACPI4S3L1	K944163	000
M724ACPI4S2R1	K944163	000
M724ACPI4S2L1	K944163	000
M724ACPI4S1R1	K944163	000
M724ACPI4S1L1	K944163	000
M724BNPI31RSIZNS1	K944163	000
M724BNPI31LSIZNS1	K944163	000
M724BNPI21RSIZNS1	K944163	000
M724BNPI21LSIZNS1	K944163	000
M724ACPI43RSIZNS1	K944163	000
M724ACPI43LSIZNS1	K944163	000
M724ACPI42RSIZNS1	K944163	000
M724ACPI42LSIZNS1	K944163	000
M724ACPI41RSIZNS1	K944163	000
M724BNPI3S1L1	K944163	000
M724BNPI3S1R1	K944163	000
M724BNPI3T1L1	K944163	000
M724BNPI2T1R1	K944163	000
M724BNPI2T1L1	K944163	000
M724ACPI4T3R1	K944163	000
M724ACPI4T3L1	K944163	000
M724ACPI4T2R1	K944163	000
M724ACPI4T2L1	K944163	000
M724ACPI4T1R1	K944163	000
M724ACPI4T1L1	K944163	000
M724ACPI1T4R1	K944163	000
M724ACPI1T4L1	K944163	000
M724ACPI1T3R1	K944163	000
M724ACPI1T3L1	K944163	000
M724ACPI1T2R1	K944163	000
M724ACPI1T2L1	K944163	000
M724ACPI1T1R1	K944163	000
M724ACPI1T1L1	K944163	000
M724ACPI41LSIZNS1	K944163	000