510(k) K902349
- Device
- SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
- Applicant
- SURGITEK
- 510(k) number
- K902349
- Product code
- FZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-05
- Date received
- 1990-05-25
- Regulation
- 878.4800
- Classification name
- Expander, Surgical, Skin Graft
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- A SALISBURY
- Address
- 3003 Rollie Gates Dr. Paso Robles CA US 93446 93446
FDA Registration Numbers#
- 1220246
- 9680411
- 3011981870
- 1032347
- 3008902714
- 3003418325
- 1058584
- 1836161
- 8043235
- 3030733800
- 3010882686
- 8010769
- 3013946322
- 9610612
- 3014334038
- 1526350
- 3004215117
- 3012883202
- 3006535925
- 2916714
- 9611112
- 3002579136
- 3026387979
- 8040278
- 3007773213
- 3023244395
- 3005809810
- 3007597038
- 3016851379
- 9613079
- 3007738736
- 3019269298
- 3022177334
- 3012507533
- 3012852163
- 3014004349
- 8030607
- 9680718
- 3005067367
- 9611194
- 9680741
- 3003807268
- 3010331645
- 3004135030
- 3035366890
- 3034525
- 9680890
- 3011137372
- 1822565
- 1319639
- 1722824
- 3022320321
- 3009134882
- 3004608878
- 3002808145
- 2132242
- 3008285983
- 3009548473
- 1526534
- 3007185216
- 3010041511
- 1222274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | Lb Medical LLC | 2008-05-02 |
| K984448 | BIRCOLL BALLOON DISSECTOR | Wells Johnson Co. | 1999-01-28 |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | General Surgical Innovations | 1997-11-14 |
| K936186 | AESCULAP SKIN GRAFT MESHER | Aesculap, Inc. | 1994-03-10 |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Inamed Development Co. | 1991-03-06 |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | Mentor Corp. | 1988-08-26 |
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-12-02 |
Legacy Summary#
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FDA Review#
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