510(k) K223052
- Device
- Peri-Guard and Supple Peri-Guard
- Applicant
- Synovis Life Technologies, Inc.
- 510(k) number
- K223052
- Product code
- FTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-07
- Date received
- 2022-09-29
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Megan Sajjad
- Address
- A Subsidiary Of Baxter International Inc.) 2575 University Ave. W. St. Paul MN US 55114 55114
FDA Registration Numbers
- 1450662
- 3013820501
- 1649390
- 1416980
- 3009493875
- 3003936139
- 3004464325
- 9617465
- 2183744
- 3009039068
- 1018470
- 3005636544
- 2023811
- 3009504230
- 2246552
- 1319660
- 1820334
- 1111225
- 2183620
- 9614442
- 2024024
- 3010513348
- 1018233
- 8010177
- 2249852
- 3013666218
- 3010600625
- 2530154
- 3003300673
- 9680579
- 3010400367
- 1835959
- 3010894343
- 3004681519
- 3009417901
- 3016429246
- 3015413883
- 1220948
- 1000393132
- 3027383505
- 3016003911
- 1526534
- 1647098
- 9615742
- 3008812560
- 3005920706
- 2245304
- 3012358417
- 3015531529
- 3002807561
- 3005497913
- 1550222
- 3005619880
- 1220477
- 2030598
- 1047843
- 3006017180
- 3012102437
- 3013307971
- 3015543569
- 3002719998
- 1048735
- 3003604053
- 3008868758
- 3000215346
- 3010178296
- 3027448274
- 1121308
- 3012448339
- 2244478
- 1818910
- 3004170064
- 1221816
- 1213643
- 3016823837
- 3036710971
- 3012547639
- 3007321028
- 3000931034
- 8043792
- 3002924436
- 3009882464
- 2132242
- 3014461810
- 3018094310
- 3003418325
- 3012669262
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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