510(k) K771190
- Device
- ABRAMSON TRACHEA HOOK & RETRACTOR
- Applicant
- Edward Weck, Inc.
- 510(k) number
- K771190
- Product code
- GDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-11
- Date received
- 1977-07-01
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006487092
- 1423537
- 3010594904
- 9614093
- 3003898360
- 9614986
- 3015512299
- 3008711893
- 3005809810
- 3036795921
- 1055890
- 3008110533
- 1421101
- 3015895045
- 3021680161
- 1054241
- 3002808270
- 9611278
- 8010733
- 3010097171
- 3013273457
- 3002769835
- 1032347
- 1220477
- 3010455030
- 3015532203
- 3002675176
- 9611274
- 3010055973
- 8043507
- 3009417901
- 3004598675
- 3007597038
- 3007589150
- 3002807115
- 3012120772
- 2084346
- 3003803182
- 9680620
- 3006142527
- 1822565
- 9611367
- 8040263
- 9680304
- 1061124
- 3005440795
- 3003435550
- 1926681
- 3015967359
- 9680735
- 1935627
- 3008338766
- 1828464
- 3003431869
- 3004215117
- 3034688516
- 3029082594
- 2916714
- 3006410968
- 1030489
- 3005528784
- 3004892425
- 2434839
- 3009051471
- 3011164188
- 3001084743
- 3035366890
- 8010099
- 8040233
- 9612086
- 2249529
- 3003244954
- 3004464325
- 9614062
- 3007675948
- 3006561161
- 3008902714
- 9681129
- 9613926
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 |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Brimfield Scientific Instruments | 1984-09-25 |
| 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 |