510(k) K844062
- Device
- Forceps & Hamostats
- Applicant
- I M, INC.
- 510(k) number
- K844062
- Product code
- GEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-18
- Date received
- 1984-10-18
- 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
- BERNARD E LADERMAN
- Address
- P.O. Box 658 Fairfield NJ US 07004 07004
FDA Registration Numbers#
- 3004215117
- 1422443
- 3003998824
- 2080222
- 3032391
- 3004892425
- 9611024
- 3008388427
- 3003541440
- 8010099
- 3010041511
- 1923569
- 3010687973
- 3009465247
- 3006487092
- 8010269
- 3005083075
- 3015173212
- 3010235355
- 1645452
- 3004519921
- 1313525
- 3010455030
- 3010220595
- 8040172
- 3013831261
- 3001620590
- 3024988980
- 8010704
- 3013946322
- 3013187142
- 1219518
- 8043895
- 3004788213
- 3009468807
- 3014908171
- 3011398162
- 3026366229
- 9680515
- 3016248634
- 9611281
- 9616538
- 3012551896
- 2529846
- 3010635845
- 8040884
- 3011196443
- 3009158523
- 3031564283
- 3008864603
- 3037407500
- 1828464
- 3005374323
- 8043441
- 3007006186
- 9616250
- 3019455
- 1818910
- 3014201171
- 3007137643
- 1417592
- 3023191945
- 3011499367
- 3017352116
- 5906
- 9616972
- 8043769
- 3016450032
- 1216677
- 8043496
- 3010155661
- 3015512299
- 3006897996
- 2183570
- 3008280196
- 1412854
- 1932180
- 1058020
- 3005809810
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 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | 1990-04-18 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | 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 |
| K884181 | MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) | Sales & Marketing Assoc. | 1988-11-10 |
| K884195 | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) | Mumtaz I. Malik | 1988-10-24 |