510(k) K822483
K822483 is an FDA 510(k) premarket notification submitted by Surgilite Intl., Inc. for the device "MULTIPLE SCRUB SUIT". The FDA issued a decision of Substantially Equivalent on September 17, 1982. The device falls under product code FXO (Suit, Surgical), a Class I device regulated under 21 CFR 878.4040. Surgilite Intl., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1982
- Date Received
- August 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suit, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type