Marco Trial Sets
FDA 510(k) K930446 · Marco Ophthalmic, Inc.
510(k) numberK930446
Submission
- Device name
- Marco Trial Sets
- Applicant
- Marco Ophthalmic, Inc.
Jacksonville, FL, US - Received
- January 26, 1993
- Decision date
- July 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HPC – Set, Lens, Trial, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1405
- Specialty
- Ophthalmic
Other 510(k)s with product code HPC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945443 | Bobes Lens SetHPC · Traditional | Bobes S.A. | 07/19/1995SE |
| K951437 | Oti Model TLS-60HPC · Traditional | Oti Medical, LLC | 04/11/1995SE |
| K930195 | Ophthalmic Trial LensesHPC · Traditional | Optimark Accessories and Instruments | 01/06/1994SE |
| K934859 | Contact LensesHPC · Traditional | Arno Intl., Inc. | 12/21/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | R.H. Burton Co. | 04/14/1993SE |
| K920571 | Trial Lens SetHPC · Traditional | R.H. Burton Co. | 05/07/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| K873907 | Confirmation TestsHPC · Traditional | Richmond Products, Inc. | 12/29/1987SE |
| K852056 | Acc Cross CylindersHPC · Traditional | Ascon Medical Instruments, Ltd. | 06/05/1985SE |
| K843095 | Tria Lens SetHPC · Traditional | Optek Medico Co., Ltd. | 10/05/1984SE |
More from Optek Medico Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K943234 | MS-30 Automatic PerimeterHPT · Traditional | 07/27/1994SE |
| K930444 | Marco Standard KeratometersHJB · Traditional | 08/09/1993SE |
| K930442 | Marco GXX Series Photographic Slit LampsHKI · Traditional | 08/09/1993SE |
| K930438 | Marco Models G,H and Primary Care Slit LampsHJO · Traditional | 08/09/1993SE |
| K930437 | Marco Standard RadiusgaugesHLF · Traditional | 08/09/1993SE |
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | 07/22/1993SE |
| K930449 | Marco, Marcotilt, Encore and Custom ChairHME · Traditional | 07/06/1993SE |
| K930447 | Marco H and TS-1 Instrument TablesHRJ · Traditional | 07/06/1993SE |
| K930443 | Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart ProjeHOS · Traditional | 07/06/1993SE |
| K930441 | Marco Standard Lensmeters 101,201HLM · Traditional | 07/06/1993SE |
Questions and answers
When was Marco Trial Sets cleared by the FDA?
Marco Trial Sets (K930446) received a 510(k) decision of Substantially Equivalent on July 6, 1993, 161 days after the submission was received.
What is the product code of K930446?
The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.