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#
- 3010097171
- 9610557
- 1424263
- 3005813597
- 3010220595
- 3013831261
- 3003644849
- 3006142527
- 3011585752
- 8010769
- 9616246
- 3004111573
- 3004552850
- 3003696170
- 1926681
- 3017521423
- 1416666
- 3006059835
- 2431166
- 3015490794
- 8043769
- 1522875
- 8043752
- 3035708926
- 3016069968
- 3006563559
- 8030973
- 2916714
- 3001620590
- 3003622639
- 1055890
- 2431425
- 1319660
- 3013503739
- 8010254
- 3017367014
- 3002090132
- 3012185136
- 3010041511
- 1000443955
- 1422443
- 3002761766
- 3006846581
- 3021969326
- 3007137643
- 3029082594
- 3008837339
- 9611024
- 3043533459
- 9681540
- 1720747
- 3005621335
- 3010235355
- 3003877407
- 8030950
- 3022320321
- 8040373
- 1055236
- 8010168
- 1928237
- 8021788
- 3004976965
- 3045857302
- 1219619
- 9611367
- 3013031133
- 9611813
- 2080222
- 3007407626
- 1423537
- 3007648354
- 9680837
- 3031231776
- 1226544
- 3008808082
- 9615857
- 9612277
- 3006210673
- 3007024186
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 |