NATRELLE INSPIRA Single Use Sizers For Gel Implants

Sizer, Mammary, Breast Implant Volume

Allergan

The following data is part of a premarket notification filed by Allergan with the FDA for Natrelle Inspira Single Use Sizers For Gel Implants.

Pre-market Notification Details

• Device ID: K203229
• 510k Number: K203229
• Device Name: NATRELLE INSPIRA Single Use Sizers For Gel Implants
• Classification: Sizer, Mammary, Breast Implant Volume
• Applicant: Allergan 2525 Dupont Dr. Irvine, CA 92612
• Contact: Kelly Carty
• Correspondent: Kelly Carty; Allergan 2525 Dupont Dr. Irvine, CA 92612
• Product Code: MRD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-02
• Decision Date: 2021-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888628045972	K203229	000
10888628045781	K203229	000
10888628045774	K203229	000
10888628045187	K203229	000
10888628045170	K203229	000
10888628045163	K203229	000
10888628045156	K203229	000
10888628045149	K203229	000
10888628045132	K203229	000
10888628045125	K203229	000
10888628045118	K203229	000
10888628045101	K203229	000
10888628045095	K203229	000
10888628045088	K203229	000
10888628045071	K203229	000
10888628045064	K203229	000
10888628045057	K203229	000
10888628045798	K203229	000
10888628045804	K203229	000
10888628045965	K203229	000
10888628045958	K203229	000
10888628045941	K203229	000
10888628045934	K203229	000
10888628045927	K203229	000
10888628045910	K203229	000
10888628045903	K203229	000
10888628045897	K203229	000
10888628045880	K203229	000
10888628045873	K203229	000
10888628045866	K203229	000
10888628045859	K203229	000
10888628045842	K203229	000
10888628045835	K203229	000
10888628045828	K203229	000
10888628045811	K203229	000
10888628045040	K203229	000