510(k) K884181
- Device
- Manual Surgical Instruments (several Models)
- Applicant
- SALES & MARKETING ASSOC.
- 510(k) number
- K884181
- Product code
- GEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-11-10
- Date received
- 1988-10-03
- Regulation
- 878.4800
- Classification name
- Forceps, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID MILLER
- Address
- 40 Industrial Rd. Berkley Heights NJ US 07922 07922
FDA Registration Numbers#
- 1935627
- 3017417635
- 3017352116
- 3007728266
- 9710524
- 3034688516
- 3012322232
- 3009468807
- 3045742729
- 9680563
- 3014967149
- 8010769
- 3012226300
- 8010168
- 3008812560
- 8040233
- 8010591
- 8010254
- 8010422
- 3010331645
- 3007518347
- 1216677
- 3002808270
- 3005841027
- 3007773213
- 1058726
- 3012507533
- 1055890
- 3010635845
- 3004892425
- 1422443
- 3003244954
- 3010399422
- 8040373
- 3010829427
- 2320762
- 8030607
- 3003536766
- 8043752
- 3036795921
- 3008719017
- 1056350
- 9680515
- 2529846
- 3032747418
- 9611827
- 3003407244
- 9614986
- 3004519921
- 1923569
- 9680718
- 8010665
- 1219619
- 2916714
- 1720747
- 3006455037
- 3003696170
- 3023657851
- 9616916
- 3013503739
- 3007187674
- 3005067367
- 9611283
- 3002090132
- 3019455
- 9680837
- 3002761766
- 8043441
- 1226486
- 3013846070
- 3008252904
- 3010699884
- 8031015
- 3008403546
- 3001146947
- 9681161
- 3010269591
- 3009513193
- 3014054118
- 8021788
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031828 | NATURALASE LP ND:YAG LASER | Focus Medical, LLC | 2003-07-17 |
| K953962 | FORCEPS | Biopsys Medical, Inc. | 1995-09-08 |
| K932385 | SUTURE REMOVING FORCEPS | Rocket of London, Ltd. | 1993-08-06 |
| K904723 | FORCEPS | Minto Research & Development, Inc. | 1991-07-26 |
| K911159 | PALPATION PROBE | Northgate Technologies, Inc. | 1991-03-29 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | 1990-04-18 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | 1990-04-18 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | 1989-03-22 |
| K884514 | FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL | Gatewood and Associates, Ltd. | 1988-11-17 |
| K884195 | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) | Mumtaz I. Malik | 1988-10-24 |
| K875319 | NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS | I-Tech Industries, Inc. | 1988-01-22 |