510(k) K931449
K931449 is an FDA 510(k) premarket notification submitted by Medical Sterile Products, Inc. for the device "MSP OPHTHALMIC (EYE SPUD)". The FDA issued a decision of Substantially Equivalent on August 31, 1993. The device falls under product code HNA (Spud, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Medical Sterile Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1993
- Date Received
- March 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spud, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type