510(k) K881394
- Device
- Non-sterile Suture Needles
- Applicant
- CHINA NATIONAL MEDICINES C/O HAVEL'S
- 510(k) number
- K881394
- Product code
- GDL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-08
- Date received
- 1988-04-04
- Regulation
- 878.4800
- Classification name
- Needle, Suturing, Reusable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN ROGERS
- Address
- 3726 Lonsdale Ave. Cincinnati OH US 45227 45227
FDA Registration Numbers#
- 9611112
- 3005440795
- 3019924
- 3004215117
- 2431166
- 8043507
- 9615857
- 1421879
- 1056350
- 3003761012
- 8040278
- 3035678069
- 3014615697
- 9611283
- 3010131137
- 3007597038
- 9680258
- 3010455030
- 3003244954
- 3015895045
- 3005273623
- 3004001706
- 1836161
- 3010726901
- 3029082594
- 9680515
- 3003644849
- 3016248634
- 2529846
- 3003828812
- 3015490794
- 9616246
- 2434839
- 9611503
- 3005813597
- 3003418325
- 9611367
- 2521877
- 9616250
- 8043554
- 8010257
- 1417592
- 8040233
- 8010298
- 2916714
- 1057946
- 3012501675
- 3007791573
- 3007648354
- 3008912461
- 8043467
- 3006897996
- 3005528784
- 9610612
- 3036795921
- 3007034808
- 3026844237
- 3014334038
- 3010692967
- 3011371465
- 3005809810
- 9710524
- 8040573
- 1416891
- 2248180
- 3003969055
- 3003807268
- 3014276972
- 3022320321
- 3008770252
- 3004552850
- 3043533459
- 9680518
- 1926681
- 1421101
- 9610905
- 8030607
- 9680619
- 8010433
- 3022862651
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851781 | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | Artiberia | 1985-06-20 |
| K851782 | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | Artiberia | 1985-06-20 |
| K813589 | SHARTPOINT EYED NEEDLES | S. Jackson, Inc. | 1982-01-18 |
| K812566 | UNIVERSAL SUTURE PASSER | Ortho Pared Instruments, Inc. | 1981-11-10 |