510(k) K863988
- Device
- THORTON TITANIUM HOOK ANGLED RIGHT
- Applicant
- KEELER INSTRUMENTS, INC.
- 510(k) number
- K863988
- Product code
- HNQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-31
- Date received
- 1986-10-14
- Regulation
- 886.4350
- Classification name
- Hook, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VAN ARSDALE
- Address
- 456 Pkwy. Broomall PA US 19008 19008
FDA Registration Numbers#
- 3008280196
- 1045379
- 3014334038
- 2529846
- 3013938829
- 1424263
- 8040381
- 3007589150
- 3017857440
- 3030446844
- 8021817
- 1923569
- 3005225959
- 3003972428
- 3004608878
- 1649914
- 1935627
- 1057946
- 3006550126
- 8043441
- 9616250
- 3005440795
- 3004552850
- 1926681
- 3030451558
- 2031959
- 2431166
- 2434839
- 3032747418
- 3010687973
- 3011371465
- 3012733432
- 3013497507
- 1054811
- 3005067367
- 9616972
- 3011137372
- 3008754084
- 3003431869
- 3004001706
- 3008102042
- 3013576617
- 3003860763
- 3006234591
- 2916714
- 3013671177
- 1219518
- 3015177648
- 2248180
- 3002834291
- 3008342610
- 3004571672
- 3012267976
- 9680519
- 3013503739
- 3008828237
- 3003039352
- 3005695838
- 3008808084
- 3023657851
- 3012185136
- 3013421458
- 1932180
- 9611112
- 3009504366
- 9680518
- 3010041511
- 3003435550
- 3009513193
- 1934420
- 3009027787
- 3007137643
- 3029082594
- 3002807310
- 9615010
- 3009732568
- 1720747
- 8043368
- 9611283
- 3008729892
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HNQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030471 | OPHTEC ENCLAVATION NEEDLE | Ophtec, USA | 2003-04-17 |
| K022842 | STEPHENS DISPOSABLE HOOKS | Stephens Instruments | 2002-11-01 |
| K874991 | PRISMA DISPOSABLE IRRIGATING IRIS HOOK | Advanced Surgical Products, Inc. | 1988-04-13 |
| K870440 | LOOK LENS LOOPS | Look, Inc. | 1987-02-20 |
| K864292 | DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY | Eye-Ko, Inc. | 1986-12-29 |
| K801469 | BONN MICRO IRIS HOOK (NON-STERILE) #7613 | Edward Weck, Inc. | 1980-07-28 |
| K791985 | HOOKS #'S 7600,7602,7603,7616 | Edward Weck, Inc. | 1979-10-04 |
| K770103 | HOOK, IRIS, SHEPARD U-SHAPED | Edward Weck, Inc. | 1977-01-25 |
| K770098 | HOOK, IRIS, HERSHMAN | Edward Weck, Inc. | 1977-01-24 |
Legacy Summary#
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FDA Review#
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