510(k) K870112
- Device
- STORZ ENT/OPHTHALMIC MAXI CHAIR
- Applicant
- STORZ INSTRUMENT CO.
- 510(k) number
- K870112
- Product code
- HME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-12
- Date received
- 1987-01-12
- Regulation
- 886.1140
- Classification name
- Chair, Ophthalmic, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN REGAN
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 8020986
- 3003851947
- 3013436538
- 3005785090
- 3004784203
- 3010675798
- 3004438145
- 9617474
- 3010673832
- 3010755771
- 3014273520
- 1054713
- 9710128
- 2031962
- 3007817024
- 2242863
- 3006105501
- 3003951061
- 3007343325
- 3006766059
- 9710516
- 3006550126
- 3004095901
- 3015972897
- 3015478295
- 3009275598
- 2916273
- 3027499529
- 3005405896
- 3004441848
- 1223498
- 3042228518
- 3010726802
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HME #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Marco Ophthalmic, Inc. | 1993-07-06 |
| K914416 | BREATH-EASY, MODIFICATION | Icor AB | 1992-06-23 |
| K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR | Reliance Medical Products, Inc. | 1989-09-12 |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 |
| K864574 | MAC 150E OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 |
| K863728 | THE ERGOSYSTEM CHAIR | Charles D. Bell, Inc. | 1986-10-31 |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sds Dental, Inc. | 1986-09-24 |
| K853743 | TECHNA VISION, INC. ELECTRIC CHAIR | Techna Vision | 1985-10-17 |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | F. & F. Koenigkramer | 1985-09-05 |
| K853150 | RELIANCE 6100 | F. & F. Koenigkramer | 1985-09-05 |
| K853151 | RELIANCE 5000 | F. & F. Koenigkramer | 1985-09-05 |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Woodlyn, Inc. | 1984-06-19 |
| K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED | Vision Health Technology | 1984-03-05 |
| K801638 | A O CUSTOM II CHAIR AND STAND | American Optical Corp. | 1980-08-13 |
| K781801 | MAXI-CHAIR | Surgical Mechanical Research, Inc. | 1978-11-03 |
Legacy Summary#
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FDA Review#
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