510(k) K843136
- Device
- BRIMFIELD CANNULATED GRASPING HOOKS
- Applicant
- BRIMFIELD SCIENTIFIC INSTRUMENTS
- 510(k) number
- K843136
- Product code
- GDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-25
- Date received
- 1984-08-09
- Regulation
- 878.4800
- Classification name
- Hook, Surgical, 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#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3022862651
- 3004571672
- 3007648354
- 3013497507
- 1926681
- 1834379
- 8044098
- 3003803182
- 3005813597
- 9612420
- 3015212339
- 3035678069
- 3003418325
- 1720747
- 8010298
- 3008280196
- 9616250
- 3005440795
- 2424531
- 8040278
- 3012120772
- 3003038445
- 8040881
- 3005897698
- 9680519
- 8010890
- 8010155
- 3036795921
- 3004598675
- 3005180920
- 3004371426
- 9610621
- 3009513193
- 3012267976
- 9614093
- 9613926
- 2249529
- 3004111573
- 3001084743
- 3000286616
- 3012995405
- 1058726
- 3008693678
- 3017521423
- 3003435550
- 3004608878
- 8010733
- 3008902714
- 3015532203
- 9680837
- 2087382
- 3010055973
- 3035858921
- 1043214
- 9614986
- 3010687973
- 3016438694
- 3003675041
- 1416666
- 3023808185
- 1222188
- 3003644849
- 3011683674
- 3012185136
- 9616088
- 2529846
- 1422634
- 3011499367
- 3009420598
- 1421879
- 1424478
- 3007456622
- 3004892425
- 9680735
- 9710524
- 8043507
- 3023657851
- 1835572
- 1220477
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900069 | MODIFIED PGL ABSORBABLE STAPLE* | United States Surgical, A Division of Tyco Healthc | 1990-04-16 |
| K891898 | SKIN HOOKS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K864425 | RAYLOR(TM) DISSECTING HOOK | Cedar Surgical, Inc. | 1986-12-12 |
| K841010 | SURGICAL HOOKS, VARIOUS | Premier Dental Products Co. | 1984-05-01 |
| K812562 | SURGICAL RETRACTOR & ELASTIC STAYS, DISP | Humboldt Products | 1981-10-02 |
| K791120 | MIDDLE EAR PICKS, HOOKS CURETTES, | Xomed, Inc. | 1979-07-10 |
| K780289 | NERVE APPROXIMATER | Edward Weck, Inc. | 1978-06-14 |
| K771187 | DERMAHOOK #382-805 | Edward Weck, Inc. | 1977-07-11 |
| K771190 | ABRAMSON TRACHEA HOOK & RETRACTOR | Edward Weck, Inc. | 1977-07-11 |
Legacy Summary#
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FDA Review#
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