510(k) K761192
- Device
- DRESSING CHANGE KIT
- Applicant
- Superior Plastic Products Corp.
- 510(k) number
- K761192
- Product code
- JOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-28
- Date received
- 1976-12-06
- Regulation
- 880.6820
- Classification name
- Scissors, Medical, Disposable
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1000175697
- 3030019171
- 3004519921
- 3003887292
- 3008902714
- 3003644849
- 3010452421
- 3006157842
- 1420763
- 3007663067
- 9610694
- 3004111573
- 1824619
- 3025413691
- 1926681
- 3003807757
- 3007389672
- 2431166
- 3032747418
- 8043769
- 3009308084
- 8043752
- 9616088
- 3035708926
- 3003431869
- 3011137372
- 8010257
- 8043816
- 1420054
- 3045742729
- 3012314549
- 3001620590
- 8010569
- 3011862887
- 3002834291
- 3005024024
- 1043214
- 3008403546
- 9616916
- 3016050930
- 2433012
- 3005973280
- 3005695838
- 3010041511
- 1000443955
- 3011647251
- 3013034812
- 3003882387
- 2083544
- 9680002
- 3006554788
- 3009124884
- 3029082594
- 9611024
- 1054241
- 8040172
- 9613793
- 3007703436
- 8022787
- 1319744
- 9611283
- 2435946
- 3001084743
- 3029754081
- 3001650535
- 1422634
- 3008338766
- 8040373
- 1055236
- 1928237
- 3002675176
- 9680900
- 1412854
- 3011495142
- 3045857302
- 3010155661
- 3013524663
- 3005327291
- 2245270
- 3016965929
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K855131 | SUTURE REMOVAL KIT | Dynarex Corp. | 1986-01-13 |
| K843075 | UTILITY SCISSORS DISPOSABLE ITEMS | Greene International Corp. | 1984-09-05 |
| K812555 | DISPOSABLE SUTURE REMOVAL SCISSORS | Medcare Products | 1981-11-16 |
| K770595 | SUTURE REMOVAL SET | Abco Dealers, Inc. | 1977-05-23 |
| K770481 | SHEAR, PLASTIC HANDLE UTILITY S-475-7 | Acme United Corp. | 1977-04-29 |
| K770163 | SUTURE CUTTER | Concept, Inc. | 1977-03-30 |