510(k) K803145
- Device
- CONPHAR EYE PROTECTOR
- Applicant
- CONPHAR, INC.
- 510(k) number
- K803145
- Product code
- HMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-05
- Date received
- 1980-12-12
- Regulation
- 878.4440
- Classification name
- Pad, Eye
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2122594
- 3023341288
- 3014146451
- 3042251637
- 3034669683
- 9611024
- 1928237
- 9680284
- 3015335956
- 3005112833
- 3000268902
- 3010401517
- 3031841433
- 3011862887
- 3011529314
- 3025413691
- 1038758
- 3003835287
- 3003887292
- 3041276890
- 3027328721
- 3045978226
- 1423537
- 3010380285
- 3006633581
- 3013735158
- 3015745029
- 3021282544
- 1043214
- 3013525704
- 8022899
- 3015220641
- 9611959
- 9613910
- 3045030500
- 3008384335
- 3008973760
- 3030536686
- 3007028032
- 3008808560
- 9681702
- 3009486864
- 3013496867
- 3042228518
- 1250045
- 9681544
- 3009931872
- 3030067857
- 3044150131
- 3009540516
- 1055236
- 1932902
- 3012777736
- 3012309743
- 3042896810
- 3009648765
- 3005951403
- 3033526648
- 3005083505
- 3017297225
- 3016746332
- 3031180770
- 3011248163
- 2110898
- 1025972
- 3042272797
- 3008386507
- 3033858895
- 3006517436
- 9616872
- 3005621808
- 3009518015
- 3023339256
- 3004014222
- 3008058134
- 3013152643
- 3016450032
- 3008076203
- 3030220356
- 1018120
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940333 | EYE PAD | Certified Safety Mfg., Inc. | 1994-03-07 |
| K921349 | STERILE,DISPOSABLE EYE DRESSING | Deroyal Industries, Inc. | 1992-05-29 |
| K904896 | EYE PAD | Ulti-Med Intl., Inc. | 1990-12-05 |
| K883822 | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | Consolidated Industries of Greater Syracuse, Inc. | 1988-11-22 |
| K874411 | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Keeler Instruments, Inc. | 1988-01-27 |
| K864810 | LIDSPLINT | Precision Therapeutics, Inc. | 1987-01-20 |
| K861456 | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Pantheon Products, Inc. | 1986-07-25 |
| K860979 | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | 1986-04-04 |
| K851906 | SURGICAL EYE PACK | Xanmed Corp. | 1985-05-21 |
| K850005 | VISOPROTECT OCCULAR SHIELD | M.S.G. Health Systems, Inc. | 1985-03-20 |
| K850099 | VISOPROTECT: OCCULAR SHIELD | Rockway Enterprises, Inc. | 1985-03-20 |
| K843197 | VISITEC EYE SHIELD | Visitec Co. | 1984-10-05 |
| K802799 | EYE PADS | Secol Co. | 1980-12-17 |
| K801995 | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Medi-Spec | 1980-04-24 |
Legacy Summary#
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FDA Review#
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