510(k) K900069
- Device
- Modified Pgl Absorbable Staple*
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- 510(k) number
- K900069
- Product code
- GDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-16
- Date received
- 1990-01-04
- 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#
- Contact
- WALTER S HENNIG
- Address
- 150 Glover Ave. Norwalk CT US 06856 06856
FDA Registration Numbers#
- 3010687973
- 9612075
- 1835572
- 3015451162
- 3036795921
- 3002807115
- 3011683674
- 3023808185
- 3042172872
- 9613083
- 1421879
- 3010455030
- 1423537
- 3030531648
- 3022748632
- 1412854
- 3003597504
- 3021680161
- 3003418325
- 2084346
- 3003431869
- 8043816
- 8030607
- 8010374
- 3005726885
- 3003687489
- 9680002
- 3008280196
- 1061124
- 3008902714
- 8010298
- 9616088
- 3004111573
- 3013055499
- 3004777218
- 2183449
- 3002808270
- 3012507533
- 3003803182
- 3006059835
- 9613350
- 3014268446
- 9680519
- 3010829427
- 3002834291
- 9611102
- 3005897698
- 3007597038
- 3019404837
- 3010611926
- 3016069968
- 3012715571
- 2080222
- 3013557562
- 3002675176
- 3004608878
- 3029082594
- 3015173212
- 1058726
- 3008110533
- 3007675948
- 3011767135
- 3009255580
- 3016965929
- 3012725451
- 3008812560
- 8040263
- 3013358456
- 3035678069
- 1935627
- 9612086
- 3004892425
- 3016438694
- 3003244954
- 2183570
- 8040373
- 8010099
- 3009513193
- 3002090132
- 3004530184
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K771190 | ABRAMSON TRACHEA HOOK & RETRACTOR | Edward Weck, Inc. | 1977-07-11 |