510(k) K230577
- Device
- Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- Applicant
- Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
- 510(k) number
- K230577
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-16
- Date received
- 2023-03-01
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Muge Ersahin
- Address
- Fatih Mah. Camlik Cad No 54 Izmir TR 35410 35410
FDA Registration Numbers
- 3029897710
- 3015173212
- 1423537
- 9680887
- 3010796396
- 3006425876
- 3013410562
- 3006538822
- 9681151
- 3016844398
- 3034669683
- 3004713352
- 3008729549
- 1526350
- 3012268821
- 1651395
- 3007289408
- 3031572397
- 3005391805
- 3034629649
- 3017398283
- 3036773433
- 3017300722
- 1423395
- 2431166
- 3018058145
- 3006540014
- 3006113262
- 3008770063
- 3009443860
- 9680357
- 3007088677
- 3023228837
- 3003495693
- 3005997949
- 3030067857
- 9616088
- 3015895045
- 3019798849
- 3042245424
- 3012497308
- 1319639
- 3008252907
- 3014666579
- 3033848619
- 3001650535
- 1054241
- 3014315560
- 1928237
- 1065597
- 3016452400
- 3012595397
- 3002807090
- 3012811961
- 3030088999
- 1423625
- 3013502418
- 1018470
- 3014314985
- 9614306
- 3017636737
- 3011494917
- 3015633688
- 3016705853
- 3000268902
- 3016763307
- 1721686
- 3005142514
- 1818910
- 3014479313
- 2029015
- 3013421458
- 1921846
- 3013429557
- 3013496867
- 1123137
- 3038718579
- 1055236
- 3011554160
Source Documents
510(k) summary PDF not indicated by FDA
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