510(k) K780349
K780349 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "VAGINAL RETRACTOR". The FDA issued a decision of Substantially Equivalent on March 14, 1978. The device falls under product code HDL (Retractor, Vaginal), a Class I device regulated under 21 CFR 884.4520. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1978
- Date Received
- March 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Vaginal
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type