510(k) K872607
- Device
- INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
- Applicant
- RANDOLPH ENGINEERING, INC.
- 510(k) number
- K872607
- Product code
- HQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-05
- Date received
- 1987-07-06
- Regulation
- 886.5842
- Classification name
- Frame, Spectacle
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- RICHARD WASZKIEWICZ
- Address
- 385 S. St. Randolph MA US 02368 02368
FDA Registration Numbers
- 3021271493
- 3040391047
- 3005895460
- 3013688041
- 3003915547
- 3009780106
- 3012167124
- 3012267379
- 1225043
- 3016812022
- 1000189446
- 3011642909
- 3003851871
- 3031550993
- 3014299855
- 9617874
- 3012206774
- 3009666019
- 3031860701
- 3010862420
- 3005785003
- 3043177860
- 9616717
- 3004971437
- 3006532764
- 1000413287
- 1293762
- 3008381128
- 3017411104
- 3005211969
- 3016929296
- 3042970887
- 3004571972
- 3017774717
- 8021073
- 3014242973
- 9614869
- 3030192584
- 3012294556
- 3005147601
- 3005312815
- 3019567818
- 3017305937
- 9611602
- 3009770970
- 3016244741
- 3008754701
- 3017716067
- 3040094748
- 3010663789
- 3017432615
- 3013957868
- 3014159107
- 3038278924
- 3007699038
- 3012928492
- 3015968624
- 3034211159
- 3009275598
- 3015243992
- 3010364601
- 3009172845
- 3008485584
- 3017160888
- 3006946094
- 9617812
- 3043750614
- 9615499
- 3003022990
- 3006668442
- 9615055
- 3016170487
- 3007289540
- 3012297893
- 9710529
- 3006985180
- 3005623341
- 3011164728
- 3012931104
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQZ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952597 | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | Point of View Optical Outlet, Inc. | 1995-09-12 |
| K944313 | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | 1995-03-28 |
| K945770 | OPTICAL FRAMES | Ramada Optics, Inc. | 1994-12-15 |
| K945392 | SPECTACLE FRAME | Seo Han Corp., Ltd. | 1994-12-15 |
| K945176 | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | 1994-12-15 |
| K945350 | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| K945342 | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | 1994-11-28 |
| K945450 | FRAME, SPECTACLE | Kookje Apis Industrial Co. | 1994-11-22 |
| K945340 | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | 1994-11-22 |
| K945323 | SPECTACLE FRAME | M.Y. Vision Corp. | 1994-11-22 |
| K945123 | ARISTAR EYEWEAR, ESPRIT EYEWEAR | Aristar Inc. U.S.A. | 1994-11-22 |
| K944641 | NIL | Max-Vision (H.K.)Limited | 1994-11-14 |
| K944373 | SPECTACLE FRAMES | Custom Optical Frames, Inc. | 1994-09-28 |
| K944160 | SILHOUETTE, SUNLIMETED,ADIDAS | Silhouette Optical , Ltd. | 1994-09-28 |
| K943561 | SPECTACLE FRAME | Australian Optical Co., Inc. | 1994-09-14 |
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases