510(k) K213552
- Device
- PuraStat-RM
- Applicant
- 3-D Matrix, Inc.
- 510(k) number
- K213552
- Product code
- PHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-01
- Date received
- 2021-11-08
- Regulation
- 510(k) Premarket Notification
- Classification name
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Spirio
- Address
- 1234 Chestnut St., Suite 205 Newton MA US 02464 02464
FDA Registration Numbers#
- 3005465238
- 3016611551
- 3015528146
- 3012263097
- 3004681519
- 3005689226
Source Documents#
Other 510(k) Records For Product Code PHN #
Legacy Summary#
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FDA Review#
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