510(k) K860915
- Device
- STORZ/MAZZACCO LENS FORCEP
- Applicant
- STORZ INSTRUMENT CO.
- 510(k) number
- K860915
- Product code
- HNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-15
- Date received
- 1986-03-11
- Regulation
- 886.4350
- Classification name
- Forceps, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICK MCCARLEY
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 3014334038
- 3005595283
- 3015895045
- 3036795921
- 8010374
- 3004475955
- 2953359
- 9612074
- 9680519
- 3003972428
- 8010694
- 9613083
- 3003365815
- 1935627
- 9611502
- 3007507973
- 3004215117
- 1421879
- 2032098
- 3042940336
- 8030950
- 3019924
- 3013503739
- 9610557
- 1528142
- 3013358456
- 8040381
- 1932402
- 9612086
- 9611516
- 9616250
- 1211998
- 3003882387
- 8010099
- 3002834291
- 3009217531
- 8043368
- 2953726
- 8010254
- 3003418325
- 8043816
- 9680620
- 3010699884
- 8010372
- 3008342610
- 3008102042
- 3005528784
- 1934420
- 3005548740
- 1926681
- 3011110913
- 3042228518
- 3012037425
- 8010518
- 3003407244
- 1937310
- 3033536312
- 1045379
- 8010269
- 8010456
- 3006234743
- 1421101
- 2529392
- 3005225959
- 8040278
- 3003860763
- 1929756
- 3043533459
- 1036836
- 1226587
- 3003431869
- 3000264417
- 1720929
- 3011371465
- 3004467263
- 9610612
- 3001967056
- 9616246
- 3010055973
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HNR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022835 | STEPHENS DISPOSABLE FORCEPS | Stephens Instruments | 2002-11-01 |
| K895434 | ALCON FOLDING FORCEPS | Alcon Laboratories | 1989-12-04 |
| K891487 | SOFT LENS FOLDING BLOCK | Western Medical Products, Inc. | 1989-08-15 |
| K893199 | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR | Allergan Medical Optics | 1989-06-16 |
| K885230 | MCDONALD FOLDING FORCEPS | Alcon Laboratories | 1989-05-17 |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | Microline Pentax, Inc. | 1988-09-12 |
| K883197 | IOL IMPLANTATION FORCEPS | D & D Surgical | 1988-08-22 |
| K880274 | ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS | Advanced Surgical Products, Inc. | 1988-02-05 |
| K864183 | OPHTHALMIC SURGICAL INSTRUMENTS | Techno Ophthalmics Intl. | 1986-11-28 |
| K864266 | OPHTHALMIC KNIFE & FORCEPS | Western Medical Products, Inc. | 1986-11-28 |
| K864071 | FAULKNER FORCEPS | Staar Surgical Co. | 1986-11-13 |
| K863727 | FIXATION INSTRUMENTS | Medical Technology Development Corp. | 1986-10-31 |
| K863991 | THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND | Keeler Instruments, Inc. | 1986-10-31 |
| K863992 | THORNTON TITANIUM FORCEPS (VARIOUS TYPES) | Keeler Instruments, Inc. | 1986-10-31 |
| K864003 | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS | Allergan, Inc. | 1986-10-31 |
Legacy Summary#
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FDA Review#
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