510(k) K240042
- Device
- MOLLI 2 System
- Applicant
- Molli Surgical, Inc.
- 510(k) number
- K240042
- Product code
- NEU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-25
- Date received
- 2024-01-05
- Regulation
- 878.4300
- Classification name
- Marker, Radiographic, Implantable
- 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
- Joseph De Croos
- Address
- 50 Wellington St. E. Suite 400 Toronto CA M5E 1C8 M5E 1C8
FDA Registration Numbers
- 1450662
- 3014967969
- 3007200016
- 3013176080
- 3021008900
- 9617429
- 2183744
- 3012536737
- 3009039068
- 3009077524
- 3013012623
- 1644312
- 3005636544
- 3013649990
- 3011162972
- 3013557562
- 2951215
- 1319660
- 1721676
- 3033589330
- 3006950086
- 1226183
- 3012345110
- 3008992312
- 1064858
- 1018233
- 3012644426
- 1417485
- 3020733550
- 3030733800
- 3004904811
- 1037905
- 1625425
- 1835568
- 3002907620
- 3014653199
- 3038503932
- 2032338
- 3007738736
- 3009649442
- 3010813819
- 3007055279
- 2936485
- 9680340
- 3014579161
- 2135401
- 3018024590
- 3015439135
- 1928237
- 1000393132
- 1724474
- 3006981798
- 3005160949
- 1222780
- 3010339638
- 1825034
- 3009192245
- 3011245468
- 3000126629
- 3007366790
- 3015924373
- 3015207155
- 1211566
- 3009656988
- 3009905888
- 1647149
- 2134494
- 3008236846
- 3021179744
- 1220477
- 2020394
- 3019807891
- 3030927217
- 3010083866
- 2029275
- 1054811
- 3008492462
- 3008706707
- 1222140
- 3004111573
- 3035366890
- 3007305589
- 3016678045
- 3033536844
- 3008744062
- 1020279
- 3015225571
- 3009609358
- 3006082230
- 3014680735
- 3015309643
- 3036009309
- 3008627763
- 2022435
- 1721504
- 3018094310
- 3026851515
- 3014090621
- 3007185216
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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