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#
- 3010097171
- 3005813597
- 3003644849
- 3006142527
- 9616246
- 3035858921
- 3004111573
- 3004552850
- 1926681
- 3017521423
- 1416666
- 3006059835
- 2431166
- 8043752
- 3016069968
- 2916714
- 1055890
- 1835998
- 3002090132
- 3012185136
- 3010041511
- 1000443955
- 3015542154
- 1835572
- 3005726885
- 3007137643
- 3029082594
- 9681540
- 1720747
- 3009051471
- 3003877407
- 3022320321
- 8040373
- 1055236
- 3008110533
- 9610621
- 9611367
- 2080222
- 1423537
- 3007648354
- 9680837
- 3034676720
- 1020279
- 3031231776
- 1226544
- 9615857
- 3008808049
- 2183570
- 3004530184
- 8040278
- 3023808185
- 3008770252
- 3004464325
- 3003803182
- 3007597038
- 1526439
- 9611461
- 9611102
- 3019404837
- 3003418325
- 1313525
- 3033536312
- 3011683674
- 3007675948
- 3014201171
- 9614062
- 9611827
- 1822565
- 8010733
- 3008280196
- 3014334038
- 2529846
- 3007589150
- 3003905396
- 2424531
- 3010687973
- 3003807268
- 3005067367
- 3003431869
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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