510(k) K932534
- Device
- Isi Fenestrated Dissecting And Grasping Forceps
- Applicant
- INNOVATIVE SURGICAL, INC.
- 510(k) number
- K932534
- Product code
- GFI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-19
- Date received
- 1993-05-28
- Regulation
- 878.4800
- Classification name
- Osteotome, Manual
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK HAMBLIN
- Address
- 3071 Continental Dr., Suite 102 West Palm Beach FL US 33407 33407
FDA Registration Numbers#
- 3003687489
- 9611112
- 3020767943
- 3005440795
- 3020584246
- 3007507973
- 8010372
- 3003740112
- 3004215117
- 2249529
- 3004638600
- 1421879
- 1056350
- 3006082533
- 3012120772
- 8040278
- 3012101664
- 3010041511
- 2424531
- 1923569
- 3003477135
- 9611827
- 3006487092
- 3008338766
- 1722824
- 3042250743
- 9611283
- 3004193466
- 9613926
- 3005083075
- 3005031160
- 3007597038
- 1226544
- 3010399422
- 1313525
- 3003637761
- 3005641619
- 3009973336
- 3012507533
- 8040179
- 3020155054
- 3016237080
- 8010704
- 3002769844
- 3013946322
- 3006128100
- 3013358456
- 1219518
- 3004001706
- 1833986
- 3010667733
- 3010097171
- 1836161
- 3002858762
- 3004788213
- 3010726901
- 2531477
- 1526439
- 2436906
- 9680837
- 9611281
- 8044098
- 3008711893
- 8010395
- 3012226300
- 2027467
- 9614062
- 3002719998
- 2434839
- 3003387384
- 3003418325
- 3005874553
- 1828464
- 3008864603
- 1833506
- 3012447612
- 3013893019
- 3033536312
- 2085199
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GFI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933181 | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 | Valleylab, Inc. | 1993-11-02 |
| K920001 | HEMOLAB SILIMAT REAGENT | Biomerieux Vitek, Inc. | 1992-09-25 |
| K891887 | OSTEOTOMES, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K852541 | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | Storz Instrument Co. | 1985-07-11 |
| K842823 | CHERMEL OSTEOTOMES | Cher Mel Corp. | 1984-08-02 |