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#
- 3026326493
- 3009051471
- 3003694247
- 8044098
- 9613563
- 3005809810
- 3005641619
- 2183449
- 3015451162
- 9613079
- 3014201171
- 9680620
- 3009703496
- 9611112
- 3008114965
- 3002808270
- 1055890
- 3003675041
- 3009513193
- 3003435550
- 3011767135
- 3035678069
- 3008693678
- 8010890
- 9680519
- 3002090132
- 3038503932
- 3023155873
- 9681129
- 9680735
- 3004777218
- 9613350
- 3029082594
- 3007366790
- 9612075
- 1055236
- 9611367
- 3015532203
- 1030489
- 3004784004
- 9611461
- 3003877407
- 3003322138
- 3005813597
- 3002769835
- 9681161
- 3004001706
- 1935627
- 8010099
- 3004608878
- 3008110533
- 3013784566
- 1423537
- 3003032798
- 5906
- 3004598675
- 3012715571
- 3005987567
- 2183570
- 9611278
- 1526439
- 3007675948
- 3034688516
- 1000443955
- 3015207155
- 3003407244
- 3005595283
- 8040233
- 3014334038
- 3008770252
- 3015398570
- 1061124
- 3014268446
- 3010155661
- 3009926836
- 8043507
- 9616250
- 1828464
- 8010370
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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