EYE PAD
FDA 510(k) clearance K940333 · decided 1994-03-07
Clearance details
- K-number
- K940333
- Device name
- EYE PAD
- Applicant
- Certified Safety Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-25
- Decision date
- 1994-03-07
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HMP
- Device class
- 1
- Regulation number
- 878.4440
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERILE,DISPOSABLE EYE DRESSING (K921349) | Deroyal Industries, Inc. | 1992-05-29 |
| EYE PAD (K904896) | Ulti-Med Intl., Inc. | 1990-12-05 |
| FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (K883822) | Consolidated Industries of Greater Syracuse, Inc. | 1988-11-22 |
| DONALDSON NATURAL EYEPATCH 'PATIENT PAK' (K874411) | Keeler Instruments, Inc. | 1988-01-27 |
| LIDSPLINT (K864810) | Precision Therapeutics, Inc. | 1987-01-20 |
| SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (K861456) | Pantheon Products, Inc. | 1986-07-25 |
| DONALDSON NATURAL EYEPATCH (K860979) | Keeler Instruments, Inc. | 1986-04-04 |
| SURGICAL EYE PACK (K851906) | Xanmed Corp. | 1985-05-21 |
| VISOPROTECT: OCCULAR SHIELD (K850099) | Rockway Enterprises, Inc. | 1985-03-20 |
| VISOPROTECT OCCULAR SHIELD (K850005) | M.S.G. Health Systems, Inc. | 1985-03-20 |
| VISITEC EYE SHIELD (K843197) | Visitec Co. | 1984-10-05 |
| CONPHAR EYE PROTECTOR (K803145) | Conphar, Inc. | 1981-02-05 |
Recalls involving this device
No recalls on record reference this clearance.